May 2013 FDA Recall Drug by Actavis South Atlantic Llc
D-829-2013 - Failed Impurity/Degradation Specification; "Related Compound C"

This Class II drug recall was voluntarily initiated by Actavis South Atlantic Llc on May 15, 2013 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specification; "related compound c". The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-829-2013

Reason for Recall
Failed Impurity/Degradation Specification; "Related Compound C"
Initiated
05-15-2013
Reported
08-07-2013
Quantity
A total of 133,968 bottles (units)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65338
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.
Actavis South Atlantic LLC
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2014
Product Description About Product Description
Full technical description of the product.
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA

Batch or Lot Expiration Information

Lot# Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.