December 2020 FDA Recall Drug by Sca Pharmaceuticals, Inc.
D-0171-2021 - Subpotent drug.

This Class II drug recall was voluntarily initiated by Sca Pharmaceuticals, Inc. on December 14, 2020 for the product Drug. The FDA reported the reason for recall as subpotent drug.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0171-2021

Reason for Recall
Subpotent drug.
Initiated
12-14-2020
Reported
12-30-2020
Quantity
654 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86982
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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, Inc.
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.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2021
Product Description About Product Description
Full technical description of the product.
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232

Batch or Lot Expiration Information

Lot# Lots: 1120025012 BUD: 01/13/2021, 1120025015 BUD: 01/15/2021, 1120025272 BUD: 01/28/2021