Drug product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
D-0574-2023
Product summary
- Event
- Event 92320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,352,475 vials
- Official record key
drug-enforcement:D-0574-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Code information: Lots: 070086, 070128, Exp. 07/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-specification