Class II · Moderate risk Ongoing
Buprenorphine HCl
Reason Crystallization; identified as Buprenorphine free base
Buprenorphine HCl Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
What was recalled
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.
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1533-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Buprenorphine recalls
See all
Class II · Moderate risk Ongoing
Buprenorphine Hydrochloride
Reason Crystallization; identified as Buprenorphine free base
Class II · Moderate risk Ongoing
Buprenorphine Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Terminated
Buprenorphine Sublingual Tablets
Reason CGMP Deviations
Class III · Low risk Terminated
Buprenorphine Transdermal System
Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
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