NAFDAC Alerts Nigerians On Defective Tetracycline
The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted the public on defective tetracycline hydrochloride ophthalmic ointment.
The notification was contained in a public alert signed by the Director-General of the agency, Prof. Mojisola Adeyeye, the News Agency of Nigeria (NAN) reported yesterday.
Mrs Adeyeye stated that World Health Organisation (WHO) raised the alarm on batches of the tetracycline hydrochloride ophthalmic ointment USP one per cent for various quality issues.
She added that the affected ointment, manufactured by Navi Mumbai-based Galentic Pharma (India) Pvt Ltd, are still within valid shelf life, quoting WHO as saying “at least 55 countries received the affected batches, and the manufacturer has initiated voluntary recall for several batches.
“The WHO also stated that the manufacturer had indicated that other batches may be included in the voluntary recall.”
She said that various marketing authorisation holders exist for the product, and that the product is available under various labelling.
She said “five international procurers of the product independently conducted visual examination of random samples of stock on hand and detected a range of quality issues.
“The issues reported by each procurer were not uniform and varied from batch to batch. Some of such issues include the presence of particles, ranging in colour, size and shape on the nozzle in the cap and in the ointment inside each tube.
“Others are black spots and brown splotches on the inner foil layer of the tube, and phase separation.”
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