August 2017 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1058-2017 - Failed Moisture Limits

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on August 2, 2017 for the product Drug. The FDA reported the reason for recall as failed moisture limits. The product was distributed in Product distributed to OH, IL, PA, MI, VA and CT and the recall is currently terminated.

Recall Number: D-1058-2017

Reason for Recall
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Initiated
08-02-2017
Reported
08-16-2017
Quantity
2,880 cartons (30 unit dose blister pack per carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77881
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.
Teva Pharmaceuticals USA
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.
Product distributed to OH, IL, PA, MI, VA and CT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-28-2018
Product Description About Product Description
Full technical description of the product.
Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15

Batch or Lot Expiration Information

Lot# 3138405A, Exp 8/2017