Class II
Terminated
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)
This recall has been terminated (originally issued April 13, 2022).
- Company
- Merck Sharp & Dohme Corp
- Recall Initiated
- March 31, 2022
- Posted
- April 13, 2022
- Recall Number
- D-0746-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3600 cartons
- Firm Location
- Whitehouse Station, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Distribution
Nationwide in the USA
Lot / Code Info
Lot: U015824, Exp. 09/22.
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