Drug recall D-0574-2023
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.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Lots and codes
Lots: 070086, 070128, Exp. 07/2023
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 1,352,475 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 11, 2023
- Terminated
- December 12, 2023
Related products
- Lorazepam – drug information
- NDC 0641-6045 Lorazepam · Lorazepam 4 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6047 Lorazepam · Lorazepam 4 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6044 Lorazepam · Lorazepam 2 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6046 Lorazepam · Lorazepam 2 mg/mL · Hikma Pharmaceuticals USA Inc.