SCA Pharmaceuticals recalls Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
- Recall date
- November 20, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0147-2021
- FDA classification
- Class III
- Brand / firm
- SCA Pharmaceuticals
- Sold / distributed
- Product was distributed to three hospitals in MO & LA.
Why it was recalled
Subpotency: Out-of-specification stability test result for low potency was obtained.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
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