August 2013 FDA Recall Drug by Central Shared Services Dba Parallon
D-1062-2014 - CGMP Deviation

This Class II drug recall was voluntarily initiated by Central Shared Services Dba Parallon on August 23, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed in GA, KY, TN and the recall is currently terminated.

Recall Number: D-1062-2014

Reason for Recall
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
Initiated
08-23-2013
Reported
02-12-2014
Quantity
3764 cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66313
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.
Central Shared Services dba Parallon
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA, KY, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-04-2014
Product Description About Product Description
Full technical description of the product.
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH

Batch or Lot Expiration Information

Lot# 600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14