Drug 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.
Lots and codes
Lot: U015824, Exp. 09/22.
Recall details
- Recalling firm
- MERCK SHARP & DOHME CORP, Whitehouse Station, NJ
- Quantity
- 3600 cartons
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 31, 2022
- Terminated
- August 15, 2023
Related products
- Janumet – drug information
- NDC 0006-0575 Janumet · Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 500… · Merck Sharp & Dohme LLC
- NDC 0006-0577 Janumet · Sitagliptin Phosphate 50 mg/1; Metformin Hydrochloride 1000… · Merck Sharp & Dohme LLC