PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: April 15, 2015 Initiated: March 25, 2015 #D-0436-2015

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.

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Details

Units Affected
6,816 Bottles
Distribution
U.S. Nationwide including Puerto Rico.
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Heritage Pharmaceuticals, Inc.. Units affected: 6,816 Bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 15, 2015. Severity: Moderate. Recall number: D-0436-2015.