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.
-- Online:www.fda.gov/medwatch/report.htm
-- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available
at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the
pre-addressed form.
-- Fax: 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.
Company Contacts:
Michael Sawaya
Joseph Sawaya
1-800-258-2471
SOURCE Altaire Pharmaceuticals, Inc.
