Drug 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.
D-0527-2026
Product summary
- Firm
- ENDO USA, Inc.
- Event
- Event 98610
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34,293 vials
- Official record key
drug-enforcement:D-0527-2026
Official wording
Reason: Crystallization; identified as Buprenorphine free base
Code information: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Crystallization; identified as Buprenorphine free base