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Lubricant Eye Drops FDA Alerts

The FDA Alert(s) below may be specifically about Lubricant Eye Drops or relate to a group or class of drugs which include Lubricant Eye Drops (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 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.

  • 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 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.

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:


[09/06/2013 - Firm Press Release - FDA]