Substandard Medical Product Alert N°2/2023

TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%: substandard product alert

WHO issued this alert after five international procurers independently inspected stock samples and reported particles, black spots and brown splotches on the inner tube foil, and phase separation. The ointment treats eye infections and trachoma and is used in infants including neonates. Affected batches were supplied in bulk and in medical kits from some humanitarian organisations.¹

Health risk as statedWHO said there was no established evidence of any adverse events from the affected batches.

Issued: 22 February 2023
Issued by: World Health Organization
Name stated on packaging: Galentic Pharma (India) Pvt. Ltd, Navi Mumbai, Maharashtra, India, named in the alert as manufacturer. The product is sold under the labels of various marketing authorisation holders.
Genuine manufacturer's statement: WHO said the manufacturer had started a voluntary recall of several batches and indicated that other batches may be included.
Countries where detected: At least 55 countries received affected batches, not named on the alert page

Batches named in the alert

Batches are listed in tables 1 and 2 of the annex to the alert

Advice as stated

Remove the listed batches from circulation and do not use them. Report any suspected adverse reaction to the national regulator.

Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.

Sources

World Health Organization, Medical Product Alert N°2/2023: TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% (22 February 2023)