D-1309-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 17, 2022
- Initiation Date
- July 11, 2022
- Termination Date
- September 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 713,550 vials
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 070088, exp. date 07/2023