The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting
the public on defective tetracycline hydrochloride ophthalmic ointment.
The notification is contained in a public alert with No. 04/2023, signed by the Director-General of the agency, Prof. Mojisola Adeyeye, issued on Tuesday in Abuja.
Adeyeye stated that 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, 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.
“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 preventive measure for infants, including neonates.”
The NAFDAC boss, however, stated that there is currently no established evidence of any adverse events from the affected batches of the product, saying that redness and swollen eyes are common reactions to general use of tetracycline eye ointment.
She said that there is currently no indication that the above-mentioned quality issues may give rise to adverse events that are not listed in the product labelling.
She advised the public in possession of the product to discontinue sale or use and submit stock to the nearest NAFDAC office.
She also urged anyone who suffered any adverse reaction to seek prompt medical advice.
