Heritage Pharmaceuticals, Inc. recalls GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage…
- Recall date
- March 25, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0436-2015
- FDA classification
- Class II
- Brand / firm
- Heritage Pharmaceuticals, Inc.
- Sold / distributed
- U.S. Nationwide including Puerto Rico.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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