Altaire Pharmaceuticals Expands Voluntary Recall Of Multiple OTC Ophthalmic Products
Altaire Pharmaceuticals announced that it is voluntarily recalling the over-the-counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co., and Prestige Brands. 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, according to a company news release.
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.
To date, Altaire has not received any reports of adverse events 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 |
Any questions regarding the voluntary recall 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.