Hikma Pharmaceuticals USA Inc. recalls Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:
Recalled September 2, 2020 · FDA recall D-1533-2020 · Hikma Pharmaceuticals USA
Hazard
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. · FDA Class II
Units
97,890 vials
Sold at
Nationwide in the U.S.
Description
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Product
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
Manufacturer(s)
Hikma Pharmaceuticals USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →