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
Reported: August 17, 2022 Initiated: July 11, 2022 #D-1307-2022
Product Description
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.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 4,739,000 vials
- Distribution
- Nationwide in the USA
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 4,739,000 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 17, 2022. Severity: Moderate. Recall number: D-1307-2022.
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