D-0596-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 24, 2026
- Initiation Date
- June 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,334 units
Product Description
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Reason for Recall
Crystallization; identified as Buprenorphine free base
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027