FDA-Drug2022-08-17Class II

Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01

Hikma Pharmaceuticals USA Inc.
Hazard

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Sold states
Nationwide in the USA
Affected count
301,400 vials
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1308-2022

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