D-0746-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2022
- Initiation Date
- March 31, 2022
- Termination Date
- August 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3600 cartons
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot: U015824, Exp. 09/22.