FDA recall D-0436-2015

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 for recall

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

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2015-03-25

Report date

2015-04-15

Termination date

2017-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2015