Falsified Medical Product Alert N°11/2019
Augmentin and Amoxicillin Clavulanate Potassium, and Bactoclav (amoxicillin and clavulanic acid): falsified product alert
WHO issued this alert on two falsified amoxicillin and clavulanic acid products found in a pharmacy in Haiti and reported by Haiti's Ministère de la Santé Publique et de la Population and CARPHA's VigiCarib network. Laboratory testing was being arranged. The Bactoclav packaging is in French with spelling errors.1
- Issued
- 16 October 2019
- Issued by
- World Health Organization
- Name stated on packaging
- Augmentin product: company details are in a table image on the alert page. Bactoclav: WHO reported that MYLAN does not manufacture, sub-contract or distribute the product.
- Genuine manufacturer's statement
- WHO said the stated manufacturer of the Augmentin product confirmed it did not manufacture this falsified version and that label details do not match genuine records. WHO said MYLAN does not manufacture, sub-contract the manufacture of, or distribute Bactoclav anywhere in the world.
- Countries where detected
- Haiti
Batches named in the alert
35405327A (Augmentin and Amoxicillin Clavulanate Potassium), BSTU0039 (Bactoclav)
Advice as stated
Do not use the listed products. Anyone who has taken them or had an adverse event or lack of efficacy should seek advice from a health professional and report it to the national authorities. Obtain medical products only from authentic and reliable sources.
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°11/2019: Falsified Amoxicillin + Clavulanic Acid products (16 October 2019)