Reported Dec 23, 2020 · Terminated

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

SCA Pharmaceuticals

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: SCA Pharmaceuticals · 755 Rainbow Rd Ste B · Windsor, CT · 06095-1024

Is this the product you have?

  • Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Lot codes and dates
    • Lot #: 1220021578
    • Exp 12/2/2020
    • 1220021732
    • Exp 12/9/2020
    • 1220022385
    • Exp 12/29/2020
    • 1220022582
    • Exp 1/6/2021
Amount recalled
4,843 syringes

Where it was sold

Why it was recalled

Subpotency: Out-of-specification stability test result for low potency was obtained.

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

Notice updated Jun 24, 2021 · Data as of Sep 19, 6:36 PM UTC

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