FDAFDA · Food and drugs·Recall number D-1533-2020
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.
Published September 2, 2020 · Recall initiated: August 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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