Inadequate Labeling on Ophthalmic Drugs Draws Warnings for Akorn, Bausch + Lomb

Akorn and Bausch + Lomb have received warning letters from the FDA for marketing unapproved ophthalmic drugs containing pilocarpine hydrochloride at various strengths.

Because the products require a prescription, their current labeling lacks adequate instructions for use, the agency said in separate warning letters posted to its website Tuesday.

In both cases, the FDA said it would not take action against the companies as long as they agree to stop manufacturing the products within 90 days and halt interstate shipments within 180 days.

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