Urgent recall of Aureomycine 1% ointment due to non-compliance
The Moroccan Agency for Medicines and Health Products (AMMPS) has mandated the immediate recall of several batches of the ophthalmic ointment Aureomycine 1%, commonly known as the yellow ointment, which contains chlorotetracycline hydrochloride in 5 g tubes.
This decision follows the identification of a non-compliance issue regarding the product's appearance, revealed during real-condition stability testing.
The affected batches, numbered 22043, 22046, and 23001, must be promptly withdrawn from wholesalers, pharmacies, and hospital facilities in accordance with AMMPS instructions. The agency has urged health professionals and distributors to halt all sales and usage of the Aureomycine 1% ointment from the specified batches.
Additionally, Promopharm, the pharmaceutical establishment responsible for manufacturing these products, is required to submit a detailed report to AMMPS. This report should include an account of the quantities distributed and retrieved, along with a record of the destruction of the recalled batches.
Furthermore, an informational letter intended for health professionals must be approved by the administration before it can be disseminated.
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