FDA-Drug2022-04-13Class II

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)

MERCK SHARP & DOHME CORP
Hazard

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

Sold states
Nationwide in the USA
Affected count
3600 cartons
Manufactured in
1 Merck Dr, Whitehouse Station, NJ, United States
Products
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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0746-2022

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