COMPANY ANNOUNCEMENT
Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionDue to lack of sterility assurance
- Company Name:
- Altaire Pharmaceuticals Inc.
- Brand Name:
-
Brand Name(s)Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige
- Product Description:
-
Product DescriptionOver-The-Counter Ophthalmic Products
Company Announcement
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.
- 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.
Company Contact Information
- Consumers:
- Altaire Pharmaceuticals Inc.
- 1-800-258-2471
- otcdruggist@aol.com