WHO alert, 22 February 2023
N°2/2023: Tetracycline hydrochloride ophthalmic ointment USP 1%: Galentic Pharma
Last checked 20 September 2026
On 22 February 2023 the WHO alerted regulators to batches of tetracycline hydrochloride ophthalmic ointment USP 1% manufactured by Galentic Pharma (India) that did not meet quality specifications. The affected batches showed particles and phase separation of the ointment base. The product had been distributed to about 55 countries, largely through humanitarian medical kits supplied by international agencies, so the alert asked recipients of such kits to quarantine the affected batches. No injuries were reported in the alert.
India link: Manufacturer in Navi Mumbai; distributed to about 55 countries through humanitarian medical kits
WHO Medical Product Alert N°2/2023: Tetracycline hydrochloride ophthalmic ointment
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Products named
- Tetracycline Hydrochloride Ophthalmic Ointment USP 1%
- Galentic Pharma (India) Pvt. Ltd, Navi Mumbai, India
Official sources and primary records
- WHO
- WHO