Stop sale, use of defective tetracycline ointment, NAFDAC warns

The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted members of the public to the presence of defective tetracycline hydrochloride ophthalmic ointment in the market.

It therefore in possession of the defective ointment to discard it immediately.

This is contained in a notice signed by the Director-General of the agency, Prof. Mojisola Adeyeye, issued on Tuesday in Abuja.

She said the World Health Organisation (WHO) had raised an 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, was still within valid shelf life.

She quoted the WHO as saying, “At least 55 countries received the affected batches, and the manufacturer has initiated a 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 also said, “Five international procurers of the product independently conducted a 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.

“Tetracycline Hydrochloride Ophthalmic Ointment USP one per is indicated for use in bacterial blepharitis (red, swollen, irritated, and itchy eyelids), bacterial conjunctivitis (eye discharge, redness and itching), bacterial keratitis (inflammation of the cornea), and trachoma caused by Chlamydia trachomatis.

“The product is given as treatment for infants and older children and also indicated as a preventive measure for infants, including neonates.”

She also urged anyone who suffered any adverse reaction to seek prompt medical advice.