Recall: D-1310-2022

Class II - Potentially Harmful

Class IIClassification

2022-07-11Initiated

TerminatedStatus

Hikma Pharmaceuticals USA Inc.Firm

Product

Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01

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.