By David Kabiyesi
The National Agency for Food and Drug Administration and Control (NAFDAC) has warned the general public to be wary of defective tetracycline hydrochloride ophthalmic ointment.
Director-General of the agency, Prof. Mojisola Adeyeye hinted that the World Health Organisation (WHO) had raised an alarm over the drugs recently.
She revealed that the affected ointment is manufactured by Navi Mumbai-based Galentic Pharma (India) saying that “at least 55 countries had received the affected batches, adding that Navi has commenced a voluntary recall of 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 authorization holders exist for the product and that the product is available under various labeling.
“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.” she said.
