57-11
Unlicensed immune globulin intravenous (human)
2 firms from 1 country are named on this alert. Their shipments may be detained at the port without physical examination. The oldest listing here dates to 10 September 2009.
- 2firms listed
- 1country
- 27 July 2026alert last published
- Source on FDA →accessdata.fda.gov
Why FDA issued it
Note: The revision of this Import Alert (IA) dated 04/18/2023 updates the IA name, guidance section including agency contacts, charge code language, product description section, and PAC. Changes to the import alert are bracketed by asterisks (***). Foreign establishments having a U.S. license for the manufacture of IGIV also manufacture unlicensed versions of IGIV for other countries. Only IGIV manufactured under the U.S. license and bearing the U.S. license number on its labeling may be imported into the United States unless the unlicensed version of IGIV has an Investigational New Drug (IND) application accepted by the Center for Biologics Evaluation and Research.
Quoted from the “Reason for Alert” section of the FDA page for 57-11, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.
Firms named on 57-11
| Firm | Country | Listed since | |
|---|---|---|---|
| A.D. Allen Pharmaceutical WholesalerUnit D5 , Seedbed Centre; Langston Road , Loughton, Essex UNITED KINGDOM | United Kingdom | 10 Sep 200916 yr | |
| B & S Durbin Ltd240 Northolt Road , Harrow, Middlesex UNITED KINGDOM | United Kingdom | 10 Sep 200916 yr |