Falsified Medical Product Alert N°3/2022
Intratect (human normal immunoglobulin), also labelled Immunoglobulina G Endovenosa Biotest: falsified product alert
WHO issued this alert on falsified intravenous immunoglobulin detected in Brazil in September 2021, India in February 2022, and Bolivia and Egypt in April 2022. Laboratory analysis had not been completed when the alert was issued.1
Health risk as statedWHO said the products may pose risks because they are given intravenously and their sterility, effectiveness and safety are unknown.
- Issued
- 27 May 2022
- Issued by
- World Health Organization
- Name stated on packaging
- Packaging names Biotest. Some falsified products were labelled Immunoglobulina G Endovenosa Biotest, a name Biotest says it does not use.
- Genuine manufacturer's statement
- WHO said Biotest GmbH confirmed all referenced products are falsified and does not manufacture any products with the name Immunoglobulina G Endovenosa Biotest.
- Countries where detected
- Brazil, India, Bolivia (Plurinational State of), Egypt
Batches named in the alert
Falsified lot numbers are listed in the annex to the alert
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°3/2022: Falsified Intratect (Human normal immunoglobulin) (27 May 2022)