Medicine recalls
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| The United States: Altaire Pharmaceuticals, Inc. issues voluntary recall of multiple ophthalmic products sold at Walgreens |
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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 at Walgreens listed below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed. No other lots are being recalled.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.
Product descriptions:
- Lubricant Eye Drops Moisturizing, NDC number: 0363-0185-13; Lot number: 19095
- Lubricant Eye Drops Moisturizing Twin Pack, NDC number: 0363-0185-49; Lot number: 19095
- Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, NDC number: 0363-7500-50; Lot number: TCI
- Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, NDC number: 0363-0193-13; Lot number: 19105, 19050
- Lubricant Eye Ointment PF Soothing, NDC number: 0363-0191-50; Lot number: TDB
The products are manufactured and labeled exclusively for Walgreens. Altaire ships the products labeled for Walgreens only to Walgreens. The products are distributed at the retail level by Walgreens. Altaire has also requested that Walgreens notify its customers. Altaire has notified Walgreens by e-mail on July 3, 2019 announcing the recalls of the products/lots, with specific directions for return of all units of the impacted lots.
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-ophthalmic-products-sold-walgreens
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Friday, Jul 5, 2019
Issued at HKT 14:00
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