Zim orders Tetracycline Hydrochloride Ophthalmic Ointment off the shelves
By Staff Writer
THE Medicines Control Authority of Zimbabwe (MCAZ) has ordered the immediate removal Tetracycline Hydrochloride Ophthalmic Ointment due to deficiencies in expected product quality.
According to MCAZ Chief Regulatory Officer, Caroline Samatanga through circular 5 of 2023 dated February 23 , 2023 , quality issues in the product were detected.
“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 color, 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,” she said.
All licensed Pharmaceutical Wholesalers, Pharmacies, Public and Private Clinics, and Hospitals were ordered to quarantine Tetracycline Hydrochloride Ophthalmic Ointment.
“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,” she said.
Samatanga said issues were 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.
