Drug product
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
D-1308-2022
Product summary
- Event
- Event 90583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 301,400 vials
- Official record key
drug-enforcement:D-1308-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Code information: Lot # 060064Z, Exp. 06/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification