Drug product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
D-1309-2022
Product summary
- Event
- Event 90583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 713,550 vials
- Official record key
drug-enforcement:D-1309-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Code information: Lot # 070088, exp. date 07/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification