January 2015 FDA Recall Drug by Sca Pharmaceuticals
D-0339-2015 - Labeling

This Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on January 2, 2015 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Louisiana and the recall is currently terminated.

Recall Number: D-0339-2015

Reason for Recall
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
Initiated
01-02-2015
Reported
01-21-2015
Quantity
972 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70167
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
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Louisiana
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2015
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059

Batch or Lot Expiration Information

Lot# : 20141218@41, Use by 3/18/2015; 20141226@24, Use by 3/26/2015