November 2013 FDA Recall Drug by Pfizer Inc.
D-1058-2014 - Failed Dissolution Specification; 8 hr stability timepoint

This Class III drug recall was voluntarily initiated by Pfizer Inc. on November 4, 2013 for the product Drug. The FDA reported the reason for recall as failed dissolution specification; 8 hr stability timepoint. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1058-2014

Reason for Recall
Failed Dissolution Specification; 8 hr stability timepoint
Initiated
11-04-2013
Reported
02-12-2014
Quantity
14,357 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66816
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
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.
US nationwide (including PR)
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-24-2015
Product Description About Product Description
Full technical description of the product.
Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66

Batch or Lot Expiration Information

Lot# Lot V120131