November 2020 FDA Recall Drug by Sca Pharmaceuticals
D-0147-2021 - Subpotency

This Class III drug recall was voluntarily initiated by Sca Pharmaceuticals on November 20, 2020 for the product Drug. The FDA reported the reason for recall as subpotency. The product was distributed in Product was distributed to three hospitals in MO & LA. and the recall is currently terminated.

Recall Number: D-0147-2021

Reason for Recall
Subpotency: Out-of-specification stability test result for low potency was obtained.
Initiated
11-20-2020
Reported
12-23-2020
Quantity
4,843 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86802
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SCA Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to three hospitals in MO & LA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-24-2021
Product Description About Product Description
Full technical description of the product.
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

Batch or Lot Expiration Information

Lot# : 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021