January 2017 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-0491-2017 - Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on January 19, 2017 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules; bottles of glipizide 5 mg tablets may contain glipizide 10 mg tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0491-2017

Reason for Recall
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Initiated
01-19-2017
Reported
03-08-2017
Quantity
1338 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76291
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.
Mylan Pharmaceuticals 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-20-2017
Product Description About Product Description
Full technical description of the product.
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10

Batch or Lot Expiration Information

Batch# 3074621, June 2018