Key Takeaway

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205 by SCA Pharmaceuticals was recalled on November 20, 2020. The hazard: Subpotency: Out-of-specification stability test result for low potency was obtained.

FDA Drug Class III Terminated

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

Recalled: November 20, 2020 ~4,843 syringes units affected D-0147-2021

Description

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

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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

Drugs

Company Information

SCA Pharmaceuticals

Little Rock, AR, United States

View all 107 recalls by SCA Pharmaceuticals →

Distribution

Product was distributed to three hospitals in MO & LA.

Related Recalls

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FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 7

July 20, 2023
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FDA Drug Class II

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Frequently Asked Questions

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Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

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