Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct....
FDA Recall #D-0147-2021 — Class III — November 20, 2020
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.
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,843 syringes
Distribution
Product was distributed to three hospitals in MO & LA.
Code Information
Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated