Recalls / Class II
Class IID-0087-2024
Product
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
- Brand name
- Buprenorphine Hydrochloride
- Generic name
- Buprenorphine Hydrochloride
- Active ingredient
- Buprenorphine Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 42023-179
- FDA application
- ANDA206586
- Affected lot / code info
- Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023
Why it was recalled
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Recalling firm
- Firm
- PAR Sterile Products LLC
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 870 Parkdale Rd, Rochester, Michigan 48307-1740
Distribution
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-11-09
- FDA classified
- 2023-11-04
- Posted by FDA
- 2023-11-15
- Terminated
- 2024-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0087-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.