Recalls / Class II
Class IID-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)
- Brand name
- Janumet
- Generic name
- Sitagliptin And Metformin Hydrochloride
- Active ingredients
- Metformin Hydrochloride, Sitagliptin Phosphate
- Route
- Oral
- NDCs
- 0006-0575, 0006-0577
- FDA application
- NDA022044
- Affected lot / code info
- Lot: U015824, Exp. 09/22.
Why it was recalled
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Recalling firm
- Firm
- MERCK SHARP & DOHME CORP
- Manufacturer
- Merck Sharp & Dohme LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Merck Dr, Whitehouse Station, New Jersey 08889-3400
Distribution
- Quantity
- 3600 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-03-31
- FDA classified
- 2022-04-05
- Posted by FDA
- 2022-04-13
- Terminated
- 2023-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0746-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.