Class II Recall

ENDO USA, Inc.

Product
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Reason
Crystallization; identified as Buprenorphine free base
Classification
Class II
Status
Ongoing
Lot
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.