The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted the public about a defective tetracycline hydrochloride ophthalmic ointment that is currently being circulated.
In a public alert, NAFDAC stated that batches of the ointment, manufactured by Galentic Pharma (India) Pvt Ltd, have been flagged by the World Health Organisation (WHO) for various quality issues.
According to the Director-General of NAFDAC, Prof. Mojisola Adeyeye, the affected ointment is still within its valid shelf life, and has been distributed to at least 55 countries worldwide.
Adeyeye noted that the manufacturer had initiated a voluntary recall for several batches, while indicating that other batches may also be included in the recall.
NAFDAC explained that the defective tetracycline hydrochloride ophthalmic ointment USP one per cent is used to treat bacterial blepharitis, bacterial conjunctivitis, bacterial keratitis, and trachoma caused by Chlamydia trachomatis. The product is also given as a preventive measure for infants, including neonates.
However, several quality issues have been detected in the affected batches of the product.
These 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.
NAFDAC has stated that there is no established evidence of any adverse events resulting from the affected batches of the product.
However, redness and swollen eyes are common reactions to general use of tetracycline eye ointment.
The NAFDAC boss advised the public to discontinue the use and sale of the product and submit stock to the nearest NAFDAC office.
Adeyeye also urged anyone who suffered any adverse reaction to seek prompt medical advice.
In light of this development, NAFDAC has called on the general public to exercise caution when purchasing or using pharmaceutical products, and to report any suspicious or adverse reactions to the agency.
