FDA-Drug2016-12-07Class II

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

Ascend Laboratories LLC
Hazard

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

Sold states
AL, FL, GA, SC & TN
Affected count
1739 bottles
Manufactured in
180 Summit Ave Ste 200, Montvale, NJ, United States
Products
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

Official notice

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

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