FDA-Drug2023-05-24Class II
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.
Hikma Pharmaceuticals USA Inc.
Hazard
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
1,352,475 vials
Manufactured in
2 Esterbrook Ln, N/A, Cherry Hill, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2023Don't want to check this manually?
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