MERCK SHARP & DOHME CORP recalls Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Samp…

Recall date

March 31, 2022

Source

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

Recall number

D-0746-2022

FDA classification

Class II

Brand / firm

MERCK SHARP & DOHME CORP

Sold / distributed

Nationwide in the USA

Why it was recalled

Presence of foreign substance: Presence of stainless steel particulates in tablets.

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

What was recalled

Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA, by Patheon Puerto Rico, Inc. Manati, Puerto Rico, 00674 Bottle (NDC 0006-0575-02), Carton (NDC 0006-0575-03)