Drug recall D-1310-2022
Product
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
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 # 070096, exp. date 07/2023
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 82,700 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.