October 2012 FDA Recall Drug by American Health Packaging
D-802-2013 - Failed Dissolution Test Requirements

This Class II drug recall was voluntarily initiated by American Health Packaging on October 10, 2012 for the product Drug. The FDA reported the reason for recall as failed dissolution test requirements. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-802-2013

Reason for Recall
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Initiated
10-10-2012
Reported
07-24-2013
Quantity
19060 blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65683
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.
American Health Packaging
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.
08-21-2013
Product Description About Product Description
Full technical description of the product.
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01

Batch or Lot Expiration Information

Lot# Lot 122600 Exp. 03/14