Alert Summary
This WHO Medical Product Alert refers to all batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%, manufactured by Galentic Pharma (India) Pvt. Ltd, whose shelf lives are still valid.
Various marketing authorization holders exist for TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% manufactured by Galentic Pharma (India) Pvt. Ltd, therefore, the product is available under various labelling.
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)[1]. It is given as a treatment for infants and older children and is also indicated as a preventive measure for infants (including neonates).
The site of manufacture of the affected product (located at R-673, T.T.C. MIDC Rabale, Thane-Belapur Road, Navi Mumbai - 400701, Maharashtra, India) was inspected by one of the marketing authorization holders on
20-21 December 2022 for compliance with good manufacturing practices. Some significant non-conformities were noted and these were notified to WHO on 25 January 2023.
Following concerns raised during the above-mentioned site inspection (at R-673, T.T.C. MIDC Rabale, Thane-Belapur Road, Navi Mumbai - 400701, Maharashtra, India), quality experts from five international procurers conducted visual examination of stock on hand and detected a range of quality issues with the product batches referenced in this alert (see Table 1), e.g. 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. These issues were not uniform and varied from batch to batch and as reported by procurer to procurer.
The manufacturer has initiated a voluntary recall for several batches (see Table 2). The manufacturer has indicated that other batches may be included in the voluntary recall.
[1]World Health Organization. (2013). Pocket book of hospital care for children: guidelines for the management of common childhood illnesses, 2nd ed. World Health Organization, link
Risks
The risk to patients from affected batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% is red and swollen eyes; there is no indication that the risk may be life-threatening.
The affected TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% is supplied in bulk and as a component of various medical kits supplied by United Nations agencies and international nongovernmental organizations providing humanitarian assistance. These agencies and organizations will be contacting all affected recipients with further information and guidance.
At least 55 countries received the affected batches.
Advice to regulatory authorities and the public
WHO advises regulatory authorities, healthcare professionals, and the public to detect and remove all batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% manufactured by Galentic Pharma (India) Pvt. Ltd at R-673, T.T.C. MIDC Rabale, Thane-Belapur Road, Navi Mumbai - 400701, Maharashtra, India from circulation.
WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by the affected batches of this product. Increased surveillance of the informal/unregulated market is also advised.
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If you are in possession of any of the affected products, WHO recommends not to use them. If you, or someone you know, has or may have used the affected product, or suffered an adverse reaction or unexpected side-effect after use, you are advised to seek immediate medical advice from a qualified healthcare professional who should, in turn, report the incident to the national regulatory authority and/or national pharmacovigilance centre.
National regulatory/health authorities are advised to immediately notify WHO if any of these products are discovered in their respective country. Please contact WHO via [email protected]
Please see Annex for details of the substandard products referenced in Alert N°2/2023.
WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products
