October 2012 FDA Recall Drug by Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals
D-010-2013 - Tablet Separation
This Class II drug recall was voluntarily initiated by Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals on October 11, 2012 for the product Drug. The FDA reported the reason for recall as tablet separation. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-010-2013
Tablet Separation: Possibility of cracked or split coating on the tablets.
10-11-2012
10-31-2012
2,755 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
12-09-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.
Batch or Lot Expiration Information
Lot# Lot C1130511A, Exp 5/13
