May 2023 FDA Recall Lorazepam by Hikma Pharmaceuticals Usa Inc.
D-0574-2023 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on May 11, 2023 for the product Lorazepam. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0574-2023

Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Initiated
05-11-2023
Reported
05-24-2023
Quantity
1,352,475 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92320
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-12-2023
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lots: 070086, 070128, Exp. 07/2023

Affected Packages Involved in this Recall

0641-6044-01 Lorazepam
0641-6044-25 Lorazepam
0641-6046-01 Lorazepam
0641-6046-10 Lorazepam
0641-6045-01 Lorazepam
0641-6045-25 Lorazepam
0641-6047-01 Lorazepam
0641-6047-10 Lorazepam