March 2015 FDA Recall Glipizide And Metformin Hcl by Heritage Pharmaceuticals, Inc.
D-0436-2015 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Heritage Pharmaceuticals, Inc. on March 25, 2015 for the product Glipizide And Metformin Hcl. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0436-2015

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Initiated
03-25-2015
Reported
04-15-2015
Quantity
6,816 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70845
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.
Heritage 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2017
Product Description About Product Description
Full technical description of the product.
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.

Batch or Lot Expiration Information

Lot# :18020994, Expiry: October 2015
Lot# : 18021311, Expiry: November 2015.

Affected Packages Involved in this Recall

23155-115-01 Glipizide And Metformin Hcl
23155-115-10 Glipizide And Metformin Hcl
23155-116-01 Glipizide And Metformin Hcl
23155-116-10 Glipizide And Metformin Hcl
23155-117-01 Glipizide And Metformin Hcl
23155-117-10 Glipizide And Metformin Hcl