The National Agency for Food and Drug Administration and Control yesterday alerted the public on defective tetracycline hydrochloride ophthalmic ointment.
NAFDAC Director-General, Prof. Mojisola Adeyeye, in a public alert, noted that the World Health Organisation had raised the alarm on batches of the tetracycline hydrochloride ophthalmic ointment USP one per cent for various quality issues.
She said the affected ointment, manufactured by Navi Mumbai-based Galentic Pharma (India) Pvt Ltd, were 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 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.