Why it was recalled
Presence of foreign substance: Presence of stainless steel particulates in tablets.
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)
Lot numbers, UPCs & expiration codes
Lot: U015824, Exp. 09/22.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0746-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 31, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 3600 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MERCK SHARP & DOHME CORP
Original FDA data
Every field from FDA enforcement report D-0746-2022, exactly as published.
Show all FDA fields
- City
- Whitehouse Station
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89893
- Address
- 1 Merck Dr
- Code information
- Lot: U015824, Exp. 09/22.
- Postal code
- 08889-3400
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0746-2022
- Classification
- Class II
- Recalling firm
- MERCK SHARP & DOHME CORP
- Product quantity
- 3600 cartons
- Termination date
- Aug 15, 2023
- Reason for recall
- Presence of foreign substance: Presence of stainless steel particulates in tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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)
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 31, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2022