FDA recall D-0746-2022

Product

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)

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-03-31

Report date

2022-04-13

Termination date

2023-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Whitehouse Station, NJ, United States

Primary source

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