The Medicines Control Authority of Zimbabwe (MCAZ) has ordered health institutions to withdraw Tetracycline Hydrochloride Ophthalmic Ointment after quality-related issues were detected.
Mrs Caroline Samatanga, MCAZ Chief Regulatory Officer in the Licensing and Enforcement Division, said the Tetracycline Hydrochloride Ophthalmic Ointment alert report indicated that a range of quality issues was detected upon physical examination of random samples of the following product batches:
AF20011, AF21160, AF21161, AF22031, AF22032, AF22093, AF22100, AF22101, AF22107, AF20097, AF22021, AF22105, AF20060A, AF22025, AF22026 & AF22061.
Health Times cite Samatanga as saying:
Reference is made to WHO product alert No. 2/2023 for Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, which was received on the 22nd of February 2023. Quality issues detected included particles ranging in colour, size, and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation.
The above are further instructed to advise the Authority of their stock status if they have any of the affected batches.
The Authority shall communicate a plan of action once investigations are complete.
Tetracycline ophthalmic preparations are used to treat infections of the eye. They may also be used along with other medicines that are taken by mouth for infections of the eye. Tetracyclines are available only with your doctor’s prescription.