Public Alert No:004/2023 – WHO Alert on Tetracycline Hydrochloride Ophthalmic Ointment USP 1%
February 27, 2023,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that the World Health Organisation (WHO) has raised alarm on batches of tetracycline hydrochloride ophthalmic ointment USP 1%, an ophthalmic antibiotic manufactured by Navi Mumbai-based Galentic Pharma (India) Pvt Ltd for various quality issues. The affected batches are still within valid shelf life.
According to WHO, at least 55 countries received the affected batches, and the manufacturer has initiated voluntary recall for several batches. The manufacturer has indicated that other batches may be included in the voluntary recall. Also, various marketing authorization holders exist for the product manufactured by Galentic Pharma (India) Pvt. Ltd, and therefore, the product is available under various labelling.
Five international procurers of the product independently conducted visual examination of random samples of stock on hand and detected a range of quality issues with the random samples of the product batches. The issues reported by each procurer were not uniform and varied from batch to batch. Some of such issues include presence of particles ranging in colour, size and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation.
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 given as a treatment for infants and older children and is also indicated as a preventive measure for infants (including neonates).
The details of the affect product are as follows;
Product Name: Tetracycline Hydrochloride Ophthalmic Ointment USP 1%
Product Manufacturer: Galentic Pharma (India) Pvt. Ltd
Manufacturing site: R-673, T.T.C. MIDC Rabale, Thane- Belapur Road, Navi Mumbai – 400701, Maharashtra, India.
Active pharmaceutical ingredient: Tetracycline Hydrochloride
However, there is currently no established evidence of any adverse events from the affected batches of the product. Redness and swollen eyes are common reactions to general use of tetracycline eye ointment. 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.
The affected product is supplied in bulk and as a component of various medical kits supplied by United Nations agencies and international non-governmental organizations providing humanitarian assistance.
Although the product is not in NAFDAC database, importers, distributors, retailers and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the affected batches of the product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the above listed products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
If you have these batches of products, please DO NOT use them. If you, or someone you know, have used these products, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the nearest NAFDAC office, or use the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on firstname.lastname@example.org