Medicine recalls
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| The United States: Altaire Pharmaceuticals, Inc. issues voluntary recall of multiple Over-the-Counter ophthalmic products sold by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige |
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The US Food and Drug Administration (FDA) announces that Altaire Pharmaceuticals, Inc. 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. 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. 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 specification results, including in-house and third party sterility testing, for the products.
The affected products are:
Accutome
- Accutome Accu-WASH 4 FL. OZ.
Focus Laboratories
- FreshKote Lubricant Eye Drops 15 mL
Grandall Distributing Co. Inc.
- Grandall Colirio Ojo De Aguila Eye Drops 15 mL
- Grandall Colirio Oftal-Mycin Redness Relief Eye Drops 15 mL
- Grandall Oftal-Mycin Ophthalmic Ointment 3.5 g
Prestige
- Clear Eyes Redness Relief 15 mL
- Clear Eyes Redness Relief 30 mL
- Clear Eyes Redness Relief (Handy Pocket Pal) 0.2 FL. Oz.
- Clear Eyes Redness Relief (Little Drug) 0.2 FL. Oz.
- Clear Eyes Redness Relief (Select Corp) 0.2 FL. Oz.
Details of the affected products (including the lot numbers) are available in the FDA website.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-over-counter-ophthalmic-products-sold
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Jul 18, 2019
Issued at HKT 17:00
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