Contaminated Medical Product Alert N°8/2022
METHOTREX (methotrexate) 50mg: contaminated product alert
WHO issued this alert after health authorities in Yemen and Lebanon tested unopened vials following adverse events in paediatric patients. Microbiological tests in both countries were positive for Pseudomonas aeruginosa. The batch was intended for sale only in India and supplies in Yemen and Lebanon were obtained outside the regulated supply chain.1,2
- Issued
- 27 December 2022
- Issued by
- World Health Organization
- Name stated on packaging
- CELON Laboratories Pvt Ltd, the stated manufacturer
- Genuine manufacturer's statement
- WHO said CELON Laboratories confirmed the batch number, manufacturing date and expiry date combination match its internal records but had not had access to samples for confirmatory testing.
- Countries where detected
- Yemen, Lebanon
Batches named in the alert
MTI2101BAQ (manufactured 01/2021, expiry 12/2022)
Advice as stated
Do not use the affected products. Anyone who used them and had an adverse reaction should seek medical advice. Report suspected adverse events to the national regulatory authority or pharmacovigilance centre. Manufacturers should test for microbial contamination before releasing batches.
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°8/2022: Substandard (contaminated) METHOTREX 50mg (27 December 2022)
- World Health Organization, Medical Product Alert N°8/2022: annex (PDF) (27 December 2022)