Recall: D-0436-2015

Class II - Potentially Harmful

Class IIClassification

2015-03-25Initiated

TerminatedStatus

Heritage Pharmaceuticals, Inc.Firm

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.

Reason

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

Distribution

U.S. Nationwide including Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.