D-1310-2022 Class II Terminated
FDA drug recall D-1310-2022 was initiated by Hikma Pharmaceuticals USA Inc. on July 11, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. The recall status is terminated (terminated September 14, 2023). Affected quantity: 82,700 vials.
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
- 82,700 vials
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 070096, exp. date 07/2023