Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products
Altaire Pharmaceuticals, Inc., announced today that it is voluntarily recalling the prescription drug products and lots, within expiry, distributed during the time period as indicated in the tables found here and at the link 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.
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.
The products are manufactured and labeled exclusively for Perrigo Company PLC. Altaire ships the products only to Perrigo Company PLC. The products are distributed by Perrigo Company PLC.
Altaire has notified Perrigo by e-mail on July 2, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Altaire has also requested that Perrigo perform a subrecall, and that Perrigo notify its customers.
Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing email@example.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Customers 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.
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