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Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige

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

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