Metformin Hydrochloride Extended Release Tablets recalled over foreign material

Recall date

July 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sun Pharmaceutical Industries, Inc. recalls Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by:…

Recall number

D-0924-2018

FDA classification

Class II

Brand / firm

Sun Pharmaceutical Industries, Inc.

Sold / distributed

AZ

Why it was recalled

Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02