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
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.
Product(s) Affected sold at Reasor’s:
UPC Product Lot Code(s)
|67811225415||CLEAR EYES REDNESS .5 OZ 00001||Lot 16195 Exp 7/19; Lot 16211 Exp 8/19; Lot 16216 Exp 8/19|
Return Product with the affected lot code(s) to your nearest Reasor’s for a full refund.