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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

AQUEBOGUE, N.Y., July 16, 2019 /PRNewswire/ -- 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: 15 mL 

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#: 6-78112-25418-7 

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.

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. 

Company Contacts:
Michael Sawaya
Joseph Sawaya
1-800-258-2471

 

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SOURCE Altaire Pharmaceuticals, Inc.