FDA recall D-0163-2017

Product

Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10

Reason for recall

Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

Distribution

AL, FL, GA, SC & TN

Key facts

Status

Terminated

Initiation date

2016-11-02

Report date

2016-12-07

Termination date

2017-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montvale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2017