DEERFIELD (dpa-AFX) - Altaire Pharmaceuticals Inc. issued voluntary recalls for multiple Over-the-Counter or OTC ophthalmic products sold at Walmart and Walgreens stores citing potential for nonsterility. These drug products include eye drops and ophthalmic ointments.
The company also recalled certain lots of ophthalmic ointments made for Perrigo Company PLC over the same concerns.
Altaire said the recall, conducted with the knowledge of the U.S. Food and Drug Administration, is a precautionary measure. The company said it has concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.
Till now, Altaire has not received any reports of adverse events.
In the recall notice, the company stated that usage of a a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
For Walgreens, the recall was for 5 drug products, including three eye drops and two ointments. For Walmart, the recall includes many products under the Equate and Support Harmony brand names.
Altaire said the products are manufactured and labeled exclusively for Walgreens and Walmart, respectively. They are directly shipped to the respective companies, and distributed at the retail level by them.
Altaire has also requested the involved companies to notify their customers. Further, the company urged Perrigo to perform a subrecall.
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