Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Reported: December 23, 2020 Initiated: November 20, 2020 #D-0147-2021
Product Description
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Reason for Recall
Subpotency: Out-of-specification stability test result for low potency was obtained.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 4,843 syringes
- Distribution
- Product was distributed to three hospitals in MO & LA.
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205. Recalled by SCA Pharmaceuticals. Units affected: 4,843 syringes.
Why was this product recalled? ▼
Subpotency: Out-of-specification stability test result for low potency was obtained.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 23, 2020. Severity: Low. Recall number: D-0147-2021.
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