Rita Odafe
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians regarding a defective tetracycline hydrochloride ophthalmic ointment. This ointment is used to treat eye irritation and is manufactured by India-based Galentic Pharma (India) Pvt Ltd. The World Health Organisation (WHO) has raised an alarm on batches of the product due to various quality issues. The Director-General of NAFDAC, Mojisola Adeyeye, stated that the product is still within its valid shelf life.
Adeyeye reported that the manufacturer has initiated a voluntary recall for several batches, and that at least 55 countries have received the affected batches. She also mentioned that five international procurers of the product conducted a visual examination of random samples of stock on hand and detected a range of quality issues, such as particles, black spots, brown splotches, and phase separation.
Tetracycline Hydrochloride Ophthalmic Ointment USP one percent is indicated for use in bacterial blepharitis, bacterial conjunctivitis, bacterial keratitis, and trachoma caused by Chlamydia trachomatis. It is given as treatment for infants and older children, and also indicated as a preventive measure for infants, including neonates.
Adeyeye said there is currently no established evidence of any adverse effects from the affected batches of the product. However, she advised Nigerians in possession of the product to discontinue sale or use and submit stock to the nearest NAFDAC office.
