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)
Reported: April 13, 2022 Initiated: March 31, 2022 #D-0746-2022
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)
Reason for Recall
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Details
- Recalling Firm
- MERCK SHARP & DOHME CORP
- Units Affected
- 3600 cartons
- Distribution
- Nationwide in the USA
- Location
- Whitehouse Station, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by MERCK SHARP & DOHME CORP. Units affected: 3600 cartons.
Why was this product recalled? ▼
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2022. Severity: Moderate. Recall number: D-0746-2022.
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