Drug 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)
D-0746-2022
Product summary
- Event
- Event 89893
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3600 cartons
- Official record key
drug-enforcement:D-0746-2022
Official wording
Reason: Presence of foreign substance: Presence of stainless steel particulates in tablets.
Code information: Lot: U015824, Exp. 09/22.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
foreign substance