Reported Aug 17, 2022 · Terminated

Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ…

Hikma Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002

Is this the product you have?

    • 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
Lot codes and dates
    • Lot # 060064
    • Exp. 06/2023
    • 070084
    • Exp. 07/2023
    • 070126
    • Exp. 07/2023
    • 080091
    • Exp. 08/2023
    • 080060
    • Exp. 08/2023
Amount recalled
4,739,000 vials

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 14, 2023 · Data as of Sep 19, 3:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.