The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted the public to batches of a contaminated ophthalmic ointment, with the generic name, tetracycline hydrochloride ophthalmic ointment USP 1%.
Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, is an ophthalmic antibiotic produced by Navi Mumbai-based Galentic Pharma (India) Pvt Ltd. It was red-flagged by the World Health Organisation (WHO) for various quality issues.
In a statement signed by the management of NAFDAC, it was noted that the affected batches still have a valid shelf life, while members of the public in possession of the product have been advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
Tetracycline Hydrochloride Ophthalmic Ointment USP 1% 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). It is also given as a treatment for infants and older children and is also indicated as a preventive measure for infants.
The problematic product batches have not yet been linked to any confirmed adverse events, though, the statement indicated. When using tetracycline eye ointment regularly, redness and swelling of the eyes are normal side effects. There is currently no evidence to suggest that the quality problems detected in the product could result in adverse effects that are not specified on the product label.
The concerned batches were distributed to at least 55 countries, according to WHO, and the manufacturer has started a voluntary recall for a number of batches. More batches might be included in the voluntary recall, the maker has said. The product made by Galentic Pharma is also available under different labeling because there are numerous marketing authorisation holders for the product.
Random samples of the available stock were visually examined by five multinational product procurers, who found a variety of quality problems with the product batches. The problems that each procurer reported were not all the same and changed from batch to batch.
“Some of these problems include phase separation, black spots, brown splotches on the inner foil layer of the tube, and the presence of particles with varying colours, sizes, and shapes on the nozzle, in the cap, and in the ointment inside each tube”, the agency revealed.
The impacted eye ointment is provided in large quantities and as a part of several medical kits by United Nations organistions and international non-governmental organisations that provide humanitarian aid.