Drug product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
D-1307-2022
Product summary
- Event
- Event 90583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,739,000 vials
- Official record key
drug-enforcement:D-1307-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Code information: Lot # 060064, Exp. 06/2023, 070084, Exp. 07/2023, 070126, Exp. 07/2023, 080091, Exp. 08/2023, 080060, Exp. 08/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification