Drug product
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
D-0596-2026
Product summary
- Event
- Event 99237
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 46,334 units
- Official record key
drug-enforcement:D-0596-2026
Official wording
Reason: Crystallization; identified as Buprenorphine free base
Code information: Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Crystallization; identified as Buprenorphine free base