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Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.
Altaire Pharmaceuticals, Inc. announced on July 15, 2019 that it was voluntarily recalling specific over-the-counter and prescription lots of multiple ophthalmic products manufactured and distributed under the Altaire label because of concerns regarding quality assurance controls. According to the company, management initiated the recall, and FDA has determined there may be a lack of sterility assurance. The company states the recall, which is being carried out to the retail level, is a precautionary measure, and it has not received any reports of adverse events in relation to the recalled products.
Detailed information regarding each recalled product, included lot number and expiration date, can be found on FDA’s website. Adverse events may be report to FDA through the agency’s MedWatch program.