FDA-Drug2022-08-17Class II
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
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
713,550 vials
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1309-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief