Recall: D-1307-2022

Class II - Potentially Harmful

Class IIClassification

2022-07-11Initiated

TerminatedStatus

Hikma Pharmaceuticals USA Inc.Firm

Product

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.