FDA-Drug2020-09-02Class II
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.
Hikma Pharmaceuticals USA Inc.
Hazard
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Sold states
Nationwide in the U.S.
Affected count
97,890 vials
Manufactured in
2 Esterbrook Ln, N/A, Cherry Hill, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1533-2020Don't want to check this manually?
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