Recalls / Class II
Class IID-1533-2020
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.
- Brand name
- Buprenorphine Hydrochloride
- Generic name
- Buprenorphine Hydrochloride
- Active ingredient
- Buprenorphine Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 0143-9246
- FDA application
- ANDA076931
- Affected lot / code info
- Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
Why it was recalled
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, N/A, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 97,890 vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-08-14
- FDA classified
- 2020-08-21
- Posted by FDA
- 2020-09-02
- Terminated
- 2021-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1533-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.