Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Reported: May 24, 2023 Initiated: May 11, 2023 #D-0574-2023
Product Description
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 1,352,475 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 1,352,475 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0574-2023.
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