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
Reason for recall: Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Recall initiated: 20211109
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated