Glipizide And Metformin Hcl Tablet, Film Coated
FDA Recall NDC 23155-116
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Glipizide And Metformin Hcl (NDC 23155-116). A significant event, classified as Class II, was initiated on Mar 25, 2015 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification for unknown impurity."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Mar 25, 2015
Apr 15, 2015
6,816 Bottles
Recall Profile & Regulatory Data
Event ID
70845
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Heritage Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Termination Date
May 15, 2017
Product Description
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
23155-115-01Product
23155-115-10Product
23155-116-01Product
23155-116-10Product
23155-117-01Product
23155-117-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
