Reported May 8, 2024 · Completed

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by:…

Hikma Injectables USA Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Injectables USA Inc · 36 Stults Rd · Dayton, NJ · 08810-1540

Is this the product you have?

  • Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only
  • Compounded by
    • Hikma Injectables USA Inc. 2 Esterbrook Lane
    • Cherry Hill
    • NJ 08003
  • Distributed by
    • Hikma Injectables USA Inc. 36 Stults Road
    • Dayton
    • NJ 08810
    • NDC 63037-100-05
Lot codes and dates
    • Lot #: CH0324001
    • Exp. Date 3/4/2025
Amount recalled
1,895 bags

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Wrong Barcode

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:22 PM UTC

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