Soothe FDA Alerts
The FDA Alert(s) below may be specifically about Soothe or relate to a group or class of drugs which include Soothe (ocular lubricant).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for ocular lubricant
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige
Jul 16, 2019
Audience: Consumer, Health Professional, Pharmacy
July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige Brands Inc., during the time period as indicated in the tables below. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets.
Altaire further advises as follows:
TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.
TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS.
ACCUTOME
Product Description:
Accutome Accu-WASH
NDC# 63448-411-04 Product Size: 4 FL. OZ.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 16250 | 09/19 | 10/26/2016 |
| 17088 | 03/20 | 09/27/2017 |
| 17307 | 10/20 | 11/10/2017 |
| 17323 | 10/20 | 12/27/2017 |
| 18014 | 1/21 | 2/21/2018 |
| 18228 | 9/21 | 10/29/2018 |
| 18261 | 10/21 | 12/18/2018 |
| 19119 | 4/22 | 6/3/2019 |
FOCUS LABORATORIES
Product Description:
FreshKote Lubricant Eye Drops
NDC# 15821-101-15 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18095 | 4/20 | 5/15/2018 |
GRANDALL DISTRIBUTING CO., INC.
Product Description:
Grandall Colirio Ojo De Aguila Eye Drops
Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17131 | 5/20 | 8/7/2017 |
| 18031 | 1/21 | 7/11/2018 |
| 19065 | 3/22 | 5/2/2019 |
Product Description:
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops
Product Size: 15mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17008 | 01/20 | 2/2/2017 |
Product Description:
Grandall Oftal-Mycin Ophthalmic Ointment
Product Size: 3.5 g
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| QJD | 10/19 | 11/15/2016 |
| RFK | 6/20 | 8/10/2017 |
| SCB | 3/21 | 4/9/2018 |
| TBI | 2/22 | 5/22/2019 |
PRESTIGE
Product Description:
Clear Eyes Redness Relief
UPC#: 6-78112-25415-6 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 16195 | 7/19 | 8/9/2016 |
| 16211 | 8/19 | 8/30/2016 |
| 16216 | 8/19 | 9/8/2016 |
Product Description:
Clear Eyes Redness Relief
UPC#: 6-78112-25419-4 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 16205 | 7/19 | 8/16/2016 |
| 16211 | 8/19 | 8/30/2016 |
Product Description:
Clear Eyes Redness Relief (Handy Pocket Pal)
UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Oz.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 16192 | 7/19 | 9/23/2016 |
| 16203 | 7/19 | 10/14/2016 |
| 16242 | 9/19 | 11/1/2016 |
| 16280 | 10/19 | 11/7/2016 |
| 16285 | 10/19 | 12/1/2016 |
| 16300 | 11/19 | 12/15/2016 |
| 16336 | 12/19 | 1/26/2017 |
| 17002 | 1/20 | 2/3/2017 |
| 17012 | 1/20 | 2/27/2017 |
| 17051 | 2/20 | 3/30/2017 |
| 17130 | 04/20 | 06/12/2017 |
| 17147 | 05/20 | 08/29/2017 |
Product Description:
Clear Eyes Redness Relief (Little Drug)
UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Oz.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 16321 | 11/19 | 1/6/2017 |
| 16336 | 12/19 | 1/26/2017 |
| 17012 | 1/20 | 2/27/2017 |
| 17034 | 2/20 | 3/9/2017 |
| 17051 | 2/20 | 3/31/2017 |
| 17147 | 5/20 | 8/29/2017 |
Product Description:
Clear Eyes Redness Relief (Select Corp)
UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Oz.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 16192 | 7/19 | 9/26/2016 |
| 16203 | 7/19 | 10/14/2016 |
| 16321 | 11/19 | 01/10/2017 |
| 17002 | 1/20 | 2/6/2017 |
| 17034 | 2/20 | 3/9/2017 |
The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. Altaire ships the products labeled for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige only to Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige, respectively. The products are distributed at the retail level by the labelers identified herein. Altaire has also requested that the labelers each perform a subrecall.
Altaire has notified Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige by e-mail on July 16, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.
Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.
Source: FDA
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products
Jul 15, 2019
Audience: Consumer, Health Professional, Pharmacy
July 15, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the over the counter (OTC) and prescription (Rx) drug products and lots, within expiry, it has manufactured and distributed under the Altaire label and trade dress during the time period as indicated below. As a precautionary measure, Altaire is voluntarily initiating this recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.
This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in inventory on hand at any distributor to which Altaire Pharmaceuticals, Inc. has sold these products.
Altaire further advises as follows:
TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.
TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS.
Product Description:
ActivEyes Nighttime Lub Eye Ointment Preservative Free
NDC#: 59390-190-50 Product Size: 3.5 g
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SKG | 11/21 | 12/28/2018 |
| TAQ | 01/22 | 04/23/2019 |
Product Description:
Altaire Altacaine Solution
NDC#: 59390-181-13 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17205 | 07/19 | 08/31/2017 |
| 17206 | 07/19 | 09/13/2017 |
| 17271 | 09/19 | 11/08/2017 |
| 18003 | 01/20 | 03/06/2018 |
| 18097 | 04/20 | 05/11/2018 |
| 18166 | 07/20 | 07/26/2018 |
| 18227 | 09/20 | 10/05/2018 |
| 18246 | 10/20 | 11/16/2018 |
| 18317 | 12/20 | 12/18/2018 |
| 19080 | 03/21 | 04/22/2019 |
| 19106 | 04/21 | 05/21/2019 |
Product Description:
ActivEyes Altachlore Ointment
NDC#: 59390-184-50 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SAP | 1/20 | 3/16/2018 |
| SFI | 6/20 | 8/16/2018 |
| SLA | 12/20 | 1/4/2019 |
| TBM | 2/21 | 3/28/2019 |
Product Description:
ActivEyes Altachlore Solution
NDC#: 59390-183-13 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18008 | 1/20 | 8/13/2018 |
| 19050 | 2/22 | 3/18/2019 |
| 19105 | 4/22 | 6/14/2019 |
Product Description:
ActivEyes Altalube Ointment
NDC#: 59390-198-50 Product Size: 3.5 gram
| Lo Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RJH | 10/20 | 1/10/2018 |
| RLL | 12/20 | 8/22/2018 |
| SGH | 07/21 | 8/23/2018 |
| SIF | 09/21 | 10/16/2018 |
| SKC | 11/21 | 12/12/2018 |
| TCG | 03/22 | 4/22/2019 |
Product Description:
Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%
NDC#: 59390-217-02 Product Size: 2.5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18164 | 7/20 | 10/2/2018 |
Product Description:
Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%
NDC#: 59390-217-05 Product Size: 5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18164 | 7/20 | 8/15/2018 |
Product Description:
Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%
NDC#: 59390-217-10 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18164 | 7/20 | 8/15/2018 |
Product Description:
Altaire Diclofenac Sodium Solution 1%
NDC#: 59390-149-02 Product Size: 2.5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17247 | 8/19 | 11/17/2017 |
Product Description:
Altaire Diclofenac Sodium Solution 1%
NDC#: 59390-149-05 Product Size: 5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17225 | 8/19 | 10/16/2017 |
| 17247 | 8/19 | 12/26/2017 |
| 18038 | 2/20 | 3/22/2018 |
| 18162 | 6/20 | 7/18/2018 |
| 19014 | 1/21 | 2/14/2019 |
Product Description:
Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution
NDC#: 59390-205-05 Product Size: 5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17099 | 4/20 | 6/1/2017 |
| 17254 | 8/20 | 9/14/2017 |
| 17255 | 8/20 | 9/15/2017 |
| 17361 | 12/20 | 12/26/2017 |
| 17362 | 12/20 | 4/4/2018 |
| 18088 | 4/21 | 4/30/2018 |
| 18089 | 4/21 | 5/1/2018 |
| 18138 | 6/21 | 6/25/2018 |
| 18146 | 6/21 | 6/29/2018 |
| 18156 | 6/21 | 8/6/2018 |
| 18212 | 8/21 | 10/2/2018 |
| 18276 | 11/21 | 12/26/2018 |
| 19082 | 3/22 | 5/1/2019 |
| 19098 | 4/22 | 5/21/2019 |
| 16282 | 10/19 | 11/11/2016 |
| 16283 | 10/19 | 01/24/2016 |
Product Description:
Altaire Eye Wash
NDC#: 59390-175-13 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17241 | 8/20 | 8/24/2017 |
| 17322 | 10/20 | 12/21/2017 |
| 18169 | 7/20 | 7/30/2018 |
| 19052 | 2/22 | 3/29/2019 |
Product Description:
Altaire Eye Wash
NDC#: 59390-175-18 Product Size: 1 Fl. Oz.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17200 | 7/19 | 7/28/2017 |
| 17322 | 10/20 | 11/27/2017 |
| 18026 | 1/21 | 3/5/2018 |
| 18100 | 4/21 | 6/18/2018 |
| 18236 | 9/21 | 11/1/2018 |
| 19052 | 2/22 | 3/22/2019 |
Product Description:
Altaire Eye Wash
NDC#: 59390-175-35 Product Size: 4 Fl. Oz.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17087 | 3/20 | 4/18/2017 |
| 17088 | 3/20 | 4/28/2017 |
| 17109 | 4/20 | 5/15/2017 |
| 17110 | 4/20 | 6/12/2017 |
| 17306 | 10/20 | 11/1/2017 |
| 17307 | 10/20 | 11/3/2017 |
| 17318 | 10/20 | 12/21/2017 |
| 17323 | 10/20 | 1/30/2018 |
| 18014 | 1/21 | 4/10/2018 |
| 18045 | 2/21 | 4/16/2018 |
| 18059 | 3/21 | 5/29/2018 |
| 18063 | 3/21 | 4/18/2018 |
| 18117 | 5/21 | 6/14/2018 |
| 18134 | 5/21 | 8/24/2018 |
| 18228 | 9/21 | 11/2/2018 |
| 18261 | 10/21 | 1/8/2019 |
| 19119 | 4/22 | 6/3/2019 |
| 16207 | 8/19 | 09/15/2016 |
| 16233 | 8/19 | 09/29/2016 |
| 16250 | 9/19 | 10/28/2016 |
| 16268 | 10/19 | 11/04/2016 |
| 16301 | 11/19 | 12/09/2016 |
Product Description:
Altaire Goniotaire
NDC#: 59390-182-13 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17112 | 4/20 | 6/1/2017 |
| 17303 | 10/20 | 12/4/2017 |
| 18032 | 2/21 | 2/22/2018 |
| 18072 | 3/21 | 4/17/2018 |
| 18193 | 8/20 | 8/16/2018 |
| 18235 | 9/21 | 10/15/2018 |
| 18285 | 11/21 | 12/17/2018 |
| 19004 | 1/22 | 1/24/2019 |
| 19102 | 4/22 | 5/15/2019 |
| 16260 | 9/19 | 10/25/2016 |
Product Description:
Altaire Homatropaire
NDC#: 59390-192-05 Product Size: 5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17041 | 2/20 | 6/01/2017 |
| 17186 | 6/20 | 11/10/2017 |
| 18068 | 3/21 | 8/17/2018 |
Product Description:
NanoTears HA PF Multi Dose Lubricant Gel Drops
NDC#: 59390-208-10 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19122 | 4/21 | 5/31/2019 |
Product Description:
Nano Tears MO Clear Emollient Mineral Oil Lipids
NDC#: 59390- 145-10 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18052 | 2/20 | 5/16/2018 |
Product Description:
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops
NDC#: 59390-144-10 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17367 | 12/19 | 2/16/2018 |
| 18102 | 4/20 | 8/9/2018 |
| 18174 | 7/20 | 9/11/2018 |
Product Description:
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack
NDC#: 59390-144-51 Product Size: 2 x 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17367 | 12/19 | 5/16/2018 |
| 18174 | 7/20 | 8/24/2018 |
Product Description:
Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose
NDC#: 59390-141-52 Product Size: 7.5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19123 | 4/21 | 6/07/2019 |
Product Description:
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free
NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RGK | 7/19 | 11/6/2017 |
| SDA | 4/20 | 4/27/2018 |
| SFH | 6/20 | 8/16/2018 |
| TAN | 1/21 | 5/23/2019 |
Product Description:
Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free
NDC#: 59390-141-56 Product Size: 0.6 mL x 32 ct.
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RGI | 7/19 | 1/5/2018 |
| SDB | 4/20 | 5/16/2018 |
| TAA | 1/21 | 3/13/2019 |
Product Description:
Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack
NDC#: 59390-142-49 Product Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18033 | 2/20 | 8/10/2018 |
Product Description:
Nano Tears TF Clear Emollient Lubricant Gel Drops
NDC#: 59390-142-13 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18033 | 2/20 | 06/04/2018 |
Product Description:
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack
NDC#: 59390-143-51 Product Size: 2 x 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17366 | 12/19 | 1/31/2018 |
Product Description:
Nano Tears XP Clear Emollient Lubricant Gel Drops
NDC#: 59390-143-10 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17366 | 12/19 | 1/5/2018 |
| 18103 | /20 | 7/9/2018 |
| 18173 | 7/20 | 8/3/2018 |
Product Description:
Altaire Ofloxacin 0.3% Ophthalmic Solution USP
NDC#: 59390-140-05 Product Size: 5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17244 | 8/19 | 10/9/2017 |
| 18057 | 3/20 | 5/15/2018 |
| 18307 | 12/20 | 1/9/2019 |
Product Description:
ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF
NDC#: 59390-148-52 Product Size: 7.5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19015 | 1/21 | 4/2/2019 |
Product Description:
ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF
NDC#: 59390-146-52 Product Size: 7.5 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18099 | 4/20 | 4/2/2019 |
Product Description:
ActivEyes Lubricant Eye Ointment Preservative Free
NDC#: 59390-189-50 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SFE | 06/21 | 4/23/2019 |
The foregoing products are manufactured and labeled by Altaire Pharmaceuticals, Inc. Altaire has notified all distributors by e-mail on July 15, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.
Source: FDA
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS
Jul 10, 2019
Audience: Consumer, Health Professional, Pharmacy
July 10, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at CVS Health the during the time period as indicated in the tables below. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. A Retail Level recall is limited to product lots currently in inventory at the chain store.
Altaire further advises as follows:
TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.
TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS.
Product Description:
CVS Health Natural Tears Lubricant Eye Drops Preservative Free
Item#: 538397 Product Size: 0.6 mL x 32 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SEI | 5/21 | 06/20/2018 |
| SGC | 7/21 | 08/31/2018 |
| QGB | 07/19 | 09/06/2016 |
| QID | 09/19 | 11/11/2016 |
| RJC | 10/20 | 10/26/2017 |
| RCJ | 03/20 | 05/20/2017 |
| RCB | 03/20 | 03/24/2017 |
| TCJ | 03/22 | 06/03/2019 |
Product Description:
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye
Item#: 317916 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17196 | 08/19 | 10/13/2017 |
| 17192 | 09/19 | 11/14/2017 |
| 17355 | 11/19 | 12/22/2017 |
| 18024 | 01/20 | 02/27/2018 |
| 18036 | 02/20 | 03/26/2018 |
| 18237 | 09/20 | 10/31/2018 |
| 18293 | 12/20 | 12/27/2018 |
| 18105 | 04/20 | 06/06/2018 |
| 18179 | 07/20 | 08/08/2018 |
| 19040 | 2/21 | 03/26/2019 |
Product Description:
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye
Item#: 247887 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17222 | 07/19 | 09/28/2017 |
| 17386 | 12/19 | 01/15/2018 |
| 19018 | 01/21 | 03/14/2019 |
| 18016 | 01/20 | 02/19/2018 |
| 18181 | 07/20 | 08/27/2018 |
| 18104 | 04/20 | 06/08/2018 |
| 19018 | 1/21 | 06/04/2019 |
Product Description:
CVS Health Dry Eye Relief Eye Drops
Item#: 317914 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17215 | 07/19 | 08/23/2017 |
| 17239 | 08/19 | 01/02/2018 |
| 18081 | 03/21 | 04/25/2018 |
| 18207 | 08/20 | 09/04/2018 |
| 18274 | 11/21 | 11/27/2018 |
Product Description:
CVS Health Dry Eye Relief Eye Drops
Item#: 457802 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17277 | 09/19 | 10/20/2017 |
| 18006 | 01/20 | 02/22/2018 |
| 18098 | 04/21 | 02/04/2019 |
| 18006 | 1/20 | 05/30/2018 |
| 19057 | 02/22 | 03/29/2019 |
Product Description:
CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 495334 Product Size: 0.6 mL x 60 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RGF | 07/19 | 08/10/29017 |
| RHN | 08/19 | 09/29/2017 |
| RIH | 09/19 | 10/30/2017 |
| RJP | 10/19 | 11/30/2017 |
| RKN | 11/19 | 12/11/2017 |
| SDC | 04/20 | 05/10/18 |
| SFC | 06/20 | 06/28/18 |
| SFJ | 06/20 | 07/25/18 |
| SGI | 07/20 | 09/18/18 |
Product Description:
CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 994883 Product Size: 0. 6 mL x 30 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RGF | 07/19 | 08/10/2017 |
| RHN | 08/19 | 09/29/2017 |
| RIH | 09/19 | 10/23/2017 |
| RJP | 10/19 | 11/30/2017 |
| RKN | 11/19 | 12/11/2017 |
| SDC | 04/20 | 05/10/2018 |
| SFC | 06/20 | 06//28/2018 |
| SFJ | 06/20 | 07/25/2018 |
| SGI | 07/20 | 10/09/2018 |
| SKF | 11/20 | 01/04/2019 |
| TAE | 01/21 | 01/04/2019 |
Product Description:
CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief
Item#: 634634 Product Size: 0.6 mL x 30
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SEI | 5/20 | 06/20/2018 |
| TAK | 01/21 | 02/28/2019 |
Product Description:
CVS Health Lubricating Gel Drops for Anytime Use
Item#: 563420 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17238 | 08/19 | 10/24/2017 |
| 18094 | 4/20 | 8/10/2018 |
| 19058 | 02/21 | 03/25/2019 |
Product Description:
CVS Health Overnight Lubricating Eye Ointment
Item#: 881532 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RJK | 10/19 | 12/21/2017 |
| SBJ | 2/20 | 03/12/2018 |
| SFG | 6/20 | 07/19/2018 |
| SHI | 8/20 | 11/06/2018 |
| SLB | 12/20 | 02/01/2019 |
| TCM | 03/21 | 04/30/2019 |
| TDC | 4/21 | 03/20/2019 |
Product Description:
CVS Health Lubricant Eye Ointment
Item#: 247881 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SAS | 1/21 | 08/9/2018 |
| SIA | 9/21 | 02/28/2019 |
| SFE | 6/21 | 11/14/2018 |
| SAS | 1/21 | 08/9/2018 |
| SFE | 6/21 | 11/14/2018 |
| SIA | 9/21 | 02/28/2019 |
| RIE | 9/20 | 01/9/2018 |
| REH | 5/20 | 07/17/2018 |
| RAD | 1/20 | 05/4/2017 |
| TAH | 01/22 | 03/11/2019 |
Product Description:
CVS Health Extra Strength Lubricant Gel Drops
Item#: 799143 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19087 | 3/21 | 04/26/2019 |
| 17289 | 9/19 | 12/19/2017 |
| 19087 | 03/21 | 04/26/2019 |
| 18122 | 5/20 | 11/19/2018 |
Product Description:
CVS Health Extra Strength Lubricant Gel Drops Twin Pack
Item#: 258587 Product Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19087 | 03/21 | 05/29/2019 |
| 18122 | 5/20 | 11/19/2018 |
| 17289 | 9/19 | 04/20/2018 |
Product Description:
CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy
Item#: 895160 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17223 | 07/19 | 09/26/2017 |
| 17297 | 10/19 | 11/17/2017 |
| 18017 | 01/20 | 02/05/2018 |
| 18018 | 01/20 | 02/21/2018 |
| 18065 | 03/21 | 06/08/2018 |
| 18213 | 08/20 | 09/11/18 |
| 18247 | 10/21 | 11/01/18 |
Product Description:
CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack
Item#: 994881 Product Size: 2 x 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17296 | 10/19 | 07/23/2017 |
| 18094 | 04/20 | 05/11/2018 |
| 18206 | 08/20 | 09/06/2018 |
Product Description:
CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 495301 Product Size: 0.6 mL x 30ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| QHI | 08/19 | 11/18/2016 |
| QJG | 10/19 | 12/6/2016 |
| RBA | 02/20 | 03/08/2017 |
| RCF | 03/20 | 04/11/2017 |
| RCM | 03/20 | 04/28/2017 |
| RDJ | 04/20 | 06/01/2017 |
| RFA | 06/20 | 06/20/2017 |
| RHI | 08/20 | 09/28/2017 |
| RJI | 10/20 | 11/16/2017 |
| RKG | 11/20 | 12/08/2017 |
| SBF | 2/21 | 06/6/2018 |
| SDD | 04/21 | 05/23/2018 |
Product Description:
CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 457791 Product Size: 0.6 mL x 70ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| QHF | 08/19 | 10/20/2016 |
| QHI | 08/19 | 11/10/2016 |
| QLA | 12/19 | 01/05/2017 |
| RBA | 02/20 | 03/07/2017 |
| RCF | 03/20 | 04/11/2017 |
| RCM | 03/20 | 04/28/2017 |
| RDJ | 04/20 | 06/01/2017 |
| RFA | 06/20 | 06/21/2017 |
| RHI | 08/20 | 09/28/2017 |
| RJI | 10/20 | 11/16/2017 |
| RKG | 11/20 | 01/02/2018 |
| RLE | 12/20 | 01/02/2018 |
| SAE | 01/21 | 02/14/2018 |
| SBF | 02/21 | 04/11/2018 |
Product Description:
CVS Health Preservative Free Lubricant Eye Drops Advanced Relief
Item#: 563442 Product Size: 0.6 mL x 30
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RJM | 10/19 | 11/22/2017 |
| RIA | 09/19 | 10/04/2017 |
| SAN | 01/20 | 02/22/2018 |
| SFF | 06/20 | 08/02/2018 |
Product Description:
CVS Health Lubricant Eye Drops Advanced Relief
Item#: 563419 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17285 | 09/19 | 01/03/2018 |
| 18067 | 03/20 | 05/02/2018 |
| 18205 | 08/20 | 08/30/2018 |
| 18067 | 3/20 | 05/03/2018 |
Product Description:
CVS Health Fast Acting Lubricant Eye Drops Preservative Free
Item#: 994882 Product Size: 0.6 mL x 24 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RIN | 09/19 | 10/23/2017 |
| RKP | 11/19 | 01/02/2018 |
| SAR | 01/20 | 03/07/2018 |
| SCG | 03/20 | 04/17/2018 |
| SED | 5/20 | 06/07/2018 |
| SLC | 12/20 | 01/18/2019 |
| TBE | 02/21 | 04/01/2019 |
| TBL | 02/21 | 05/15/2019 |
Product Description:
CVS Health Preservative Free Lubricant Eye Drops Fast Acting
Item#: 258625 Product Size: 0.6 mL x 60 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RHD | 08/19 | 08/29/2017 |
| RIF | 09/19 | 10/17/2017 |
| RIN | 09/19 | 10/23/2017 |
| RKP | 11/19 | 01/08/2018 |
| SAR | 01/20 | 02/21/2018 |
| SCG | 03/20 | 04/17/2018 |
| SED | 5/20 | 06/7/2018 |
Product Description:
CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief
Item#: 799145 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17214 | 07/19 | 09/29/2017 |
| 18002 | 1/20 | 11/14/2018 |
| 18113 | 5/20 | 02/4/2019 |
Product Description:
CVS Health Multi-Action Relief Drops
Item#: 694954 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 16267 | 10/19 | 11/07/2016 |
| 18096 | 04/21 | 08/01/2018 |
| 18301 | 12/21 | 12/27/2018 |
| 18096 | 4/21 | 06/14/2018 |
| 18301 | 12/21 | 12/27/2018 |
| 17371 | 12/20 | 01/19/2018 |
| 17158 | 6/20 | 06/26/2017 |
| 17025 | 1/20 | 04/21/2017 |
| 17015 | 1/20 | 02/08/2017 |
| 19103 | 04/22 | 06/03/2019 |
Product Description:
CVS Health Lubricant Eye Drops Lasting Dry Eye Relief
Item#:968210 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17291 | 9/19 | 12/15/2017 |
| 17385 | 12/19 | 07/10/2018 |
| 18118 | 5/20 | 09/18/2018 |
| 18266 | 10/20 | 12/11/2018 |
Product Description:
CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack
Item#: 495323 Product Size: 2 x 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17291 | 9/19 | 12/19/2017 |
| 17385 | 12/19 | 03/23/2018 |
| 18118 | 5/20 | 08/17/2018 |
Product Description:
CVS Health Maximum Redness Relief Eye Drops
Item#: 994880 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17251 | 8/19 | 09/05/2017 |
| 17269 | 9/19 | 11/09/17 |
| 17360 | 12/19 | 01/10/2018 |
| 18012 | 1/20 | 04/20/2018 |
| 18106 | 4/20 | 05/24/2018 |
| 18275 | 11/20 | 12/05/2018 |
| 18275 | 11/20 | 12/06/2018 |
Product Description:
CVS Health Redness Relief
Item#: 317912 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18229 | 9/21 | 10/12/18 |
| 18031 | 1/21 | 04/10/2018 |
| 17131 | 5/20 | 06/19/2017 |
| 17059 | 3/20 | 06/20/2017 |
| 17008 | 1/20 | 02/01/2017 |
| 19056 | 03/22 | 05/01/2019 |
Product Description:
CVS Health Redness Relief
Item#: 457799 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18229 | 9/21 | 11/02/2018 |
| 18229 | 9/21 | 06/04/2019 |
| 19056 | 03/22 | 04/17/2019 |
Product Description:
CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief
Item#: 563431 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 18043 | 2/20 | 03/16/2018 |
| 18115 | 5/20 | 08/06/2018 |
| 18300 | 12/20 | 02/01/2019 |
| 18300 | 12/20 | 02/01/2019 |
| 18116 | 5/20 | 02/01/2019 |
| 18115 | 5/20 | 06/11/2018 |
| 18044 | 2/20 | 05/30/2018 |
| 18043 | 2/20 | 03/16/2018 |
Product Description:
CVS Health Lubricant Eye Ointment Sensitive Formula
Item#: 247885 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| QHE | 08/19 | 11/11/2016 |
| QJD | 10/19 | 01/16/2017 |
The products are manufactured and labeled exclusively for CVS Health. Altaire ships the products labeled for CVS only to CVS. The products are distributed at the retail level by CVS. Altaire has notified CVS by e-mail on July 10, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.
Source: FDA
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Wal Mart
Jul 5, 2019
Audience: Consumer, Health Professional, Pharmacy
July 5, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.
Product Description:
Equate Restore Tears Lubricant Eye Drops Twin Pack
W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17196 | 07/19 | 08/15/2017 |
| 17292 | 09/19 | 11/03/2017 |
| 17355 | 11/19 | 12/22/2017 |
| 19040 | 02/21 | 03/26/2019 |
Product Description:
Equate Eye Allergy Relief Drops
W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19128 | 05/21 | 06/20/2019 |
| 19009 | 01/21 | 01/28/2019 |
| 19003 | 01/21 | 02/21/2019 |
| 19034 | 01/21 | 03/07/2019 |
| 19060 | 02/21 | 04/22/2019 |
| 19061 | 02/21 | 05/21/2019 |
| 18252 | 10/20 | 11/21/2018 |
| 18058 | 03/20 | 03/22/2018 |
| 18224 | 09/20 | 09/26/2018 |
| 18185 | 07/20 | 08/27/2018 |
| 18152 | 06/20 | 07/05/2018 |
| 18159 | 06/20 | 07/18/2018 |
| 18091 | 04/20 | 06/07/2018 |
| 18090 | 04/20 | 04/27/2018 |
| 18069 | 03/20 | 04/04/2018 |
Product Description:
Equate Sterile Lubricant Stye Ointment
W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SAJ | 01/21 | 03/23/2018 |
| SFE | 06/21 | 07/05/2018 |
| SIA | 09/21 | 10/23/2018 |
| RIE | 09/20 | 09/28/2017 |
| REH | 05/20 | 07/21/2017 |
| RAD | 01/20 | 05/23/2017 |
| TAH | 01/22 | 02/14/2019 |
| TDD | 04/22 | 05/29/2019 |
Product Description:
Equate Comfort Gel Lubricant Eye Gel Twin Pack
W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL
Lot Number |
Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17384 | 12/19 | 01/17/2018 |
| 17259 | 08/19 | 10/27/2017 |
| 19002 | 01/21 | 01/22/2019 |
| 19041 | 02/21 | 04/09/2019 |
| 18222 | 09/20 | 09/25/2018 |
| 18084 | 04/20 | 06/15/2018 |
Product Description:
Equate Restore PM Nighttime Lubricant Eye Ointment
W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram
Lot Number |
Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| SKG | 08/21 | 12/18/2018 |
| SHK | 08/21 | 10/09/2018 |
| SHJ | 08/21 | 09/13/2018 |
| SEC | 05/21 | 07/13/2018 |
| SCB | 03/21 | 01/14/2019 |
| SBC | 02/21 | 03/21/2019 |
| RLB | 12/20 | 12/27/2017 |
| RBB | 02/20 | 04/28/2017 |
| RHR | 08/20 | 10/04/2017 |
| RFK | 06/20 | 07/28/2017 |
| RAB | 01/20 | 03/21/2017 |
| TAD | 01/22 | 01/25/2019 |
| TAQ | 01/22 | 03/18/2019 |
| TBI | 02/22 | 04/29/2019 |
| TDB | 04/22 | 06/07/2019 |
| QHE | 08/19 | 09/27/2016 |
| QJD | 10/19 | 12/07/2016 |
| SGE | 07/21 | 08/07/2018 |
Product Description:
Equate Night & Day Restore Tears Lubricant Eye Pack
W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| KT19146 | 02/21 | 06/05/2019 |
| KT18133 | 04/20 | 12/12/2018 |
| KT18194 | 07/20 | 01/15/2019 |
| KT18129 | 02/20 | 05/25/18 |
Product Description:
Equate Support Advanced Twin Pack
W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19137 | 05/22 | 06/06/2019 |
| 19022 | 01/22 | 02/18/2019 |
Product Description:
Equate Support Advanced Lubricating Eye Drops Dose Preservative Free
W-M item #: 563031654 NDC # 49035-882-54: Package Size: 25 count (0.6 mL fill):
Lot Number |
Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| RKP | 11/19 | 01/08/2018 |
| RIN | 09/19 | 12/22/2017 |
| SLC | 12/20 | 01/16/2019 |
| RIF | 09/19 | 10/10/2017 |
| TBE | 02/21 | 03/26/2019 |
| TBI | 02/21 | 05/15/2019 |
| SHB | 08/20 | 10/03/2018 |
Product Description:
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free
W-M item #: 567367998 NDC #: 49035-882-52 Package Size: 7.5 mL
Lot Number |
Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19015 | 01/21 | 02/06/2019 |
| 19117 | 04/21 | 05/20/2019 |
| 18080 | 07/20 | 08/02/2018 |
| 18111 | 05/20 | 05/25/2018 |
Product Description:
Equate Support Moisture Lubricant Eye Drops
W-M item #: 553503238 NDC #: 49035-145-10 Package Size:10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19011 | 01/21 | 04/01/2019 |
| 18052 | 02/20 | 03/26/2018 |
| 18266 | 10/20 | 01/15/2019 |
| 18178 | 07/20 | 08/20/2018 |
| 17385 | 12/19 | 01/24/2018 |
Product Description:
Support Harmony Lubricant Eye Drops
W-M item #: 553503238 NDC #: 49035-145-10 Package Size: 10 mL
(Note: Support Harmony packaging was discontinued in January 2018.)
Lot Number |
Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 17290 | 09/19 | 11/03/2017 |
The products are manufactured and labeled exclusively for Wal-Mart. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. The products are distributed at the retail level by Wal-Mart. Altaire has also requested that Wal-Mart notify its customers.
Altaire has notified Wal-Mart by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.
Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.
Source: FDA
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens
Jul 3, 2019
Audience: Consumer, Health Professional, Pharmacy
July 3, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Walgreens during the time period as indicated in the tables below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.
Product Description: Lubricant Eye Drops Moisturizing
Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19095 | 04/21 | 05/14/19 |
Product Description: Lubricant Eye Drops Moisturizing Twin Pack
Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19095 | 04/21 | 05/14/19 |
Product Description: Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment
Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| TCI | 03/21 | 05/08/2019 |
Product Description: Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops
Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| 19105 | 04/22 | 05/24/2019 |
| 19050 | 02/22 | 05/23/2019 |
Product Description: Lubricant Eye Ointment PF Soothing
Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
|---|---|---|
| TDB | 04/22 | 05/24/2019 |
The products are manufactured and labeled exclusively for Walgreens. Altaire ships the products labeled for Walgreens only to Walgreens. The products are distributed at the retail level by Walgreens. Altaire has also requested that Walgreens notify its customers.
Altaire has notified Walgreens by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.
Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday through Friday from 8:30 a.m. to 5:00 p.m. ET. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.
Source: FDA
Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry
Sep 8, 2013
Audience: Consumer, Eye Care, Pharmacy, Patient, Health Professional
ISSUE: Altaire Pharmaceuticals, Inc., announced that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. Due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall.
A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection.
BACKGROUND: Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box.
The product is labeled as follows (refer the Firm Press Release for a detailed product list containing affected lot numbers):
- equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc.
- Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc.
- lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. by Target Corp.
RECOMMENDATION: Consumers who have the product with any of the lot numbers listed in the Firm Press Release should stop use of the product immediately and return it to the place of purchase.
Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/06/2013 - Firm Press Release - FDA]
