Falsified Medical Product Alert N°1/2021
VITAMIN A (RETINOL) capsules: falsified product alert
WHO issued this alert on two falsified vitamin A capsule products identified in Chad and reported to WHO in November 2020. Both were severely degraded and underdosed, at 68.6% and 64.4% of the stated active ingredient. The products were supplied at patient level and may still be in circulation in the region.1,2
- Issued
- 10 March 2021
- Issued by
- World Health Organization
- Name stated on packaging
- Table 1 gives Accucaps Industries Limited (batch UI4004) and Banner Pharmacaps (Canada) Ltd (batch 39090439) as stated manufacturers. WHO said genuine batches with these numbers were made by those companies with much earlier dates, and that the falsified products had been tampered with. Packs carry obsolete WHO Essential Drugs Programme and Micronutrient Initiative logos.
- Genuine manufacturer's statement
- The alert does not quote the companies. WHO said the variable data (batch number and expiry dates) do not correspond to genuine manufacturing records. Genuine batch UI4004 was manufactured in September 2009 with expiry September 2012, and genuine batch 39090439 had expiry in 2009.
- Countries where detected
- Chad
Batches named in the alert
UI4004 (printed on falsified pack, stated manufacture 01/2019, expiry 09/2022), 39090439 (printed on falsified pack, stated manufacture 01/2019, expiry 09/2022)
Advice as stated
Do not use the listed products. Obtain medicines only from authorised or licensed suppliers and check their authenticity and condition. Report adverse events or suspected falsification to the national regulatory authority or pharmacovigilance centre.
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°1/2021: Falsified Vitamin A (10 March 2021)
- World Health Organization, Medical Product Alert N°1/2021: annex (PDF) (10 March 2021)