Drug recall D-1307-2022
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
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Lots and codes
Lot # 060064, Exp. 06/2023, 070084, Exp. 07/2023, 070126, Exp. 07/2023, 080091, Exp. 08/2023, 080060, Exp. 08/2023
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 4,739,000 vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 11, 2022
- Terminated
- September 14, 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.