Rwanda FDA bans two drugs amid safety concerns
Tuesday, March 12, 2024
Tetracycline eye ointment manufactured by Angel Biogenics Pvt Ltd, India. Courtesy

Rwanda Foods and Drugs Authority has recalled from the market an injection drug and an eye ointment, following complaints and safety concerns.

The regulator recalled all batches of Tetracycline eye ointment manufactured by Angel Biogenics Pvt Ltd, India following complaints about the drug, Rwanda FDA said in a statement on Monday, March 11.

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The statement said the eye ointment’s manufacturer had "voluntarily recalled the product due to discoloration.”

Patients taking the eye ointment were also asked to stop it.

The regulator also recalled Phytomenadione Injection BP 10 mg -1 ml Ampoule which is manufactured by Merit Organics.

In a statement, the regulator said the injection drug was recalled due to variation in pH, which is a measure of the level of acidity or alkalinity of a substance.

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Rwanda FDA Director General Emile Bienvenu instructed all importers, central medical stores, wholesalers, (Rwanda Medical Supply (RMS) branches, retailers, and public and private health facilities to stop the distribution and dispensing Tetracycline eye ointment and Phytomenadione Injection BP 10 mg -1 ml Ampoule.

He said the importers and suppliers of the two products are requested to report to Rwanda FDA within 10 days from the date of the announcement. The report should include quantities imported, distributed, returned, and final stock on hand.