Janumet Tablet, Film Coated
FDA Recall NDC 0006-0577
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Janumet (NDC 0006-0577). A significant event, classified as Class II, was initiated on Mar 31, 2022 by Merck Sharp & Dohme Llc. The reported reason for this action was: "Presence of foreign substance: Presence of stainless steel particulates in tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Mar 31, 2022
Apr 13, 2022
3600 cartons
Recall Profile & Regulatory Data
Event ID
89893
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
MERCK SHARP & DOHME CORP
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 15, 2023
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)
Batch or Lot Expiration Information
Lot# Lot: U015824, Exp. 09/22.
Affected Packages Involved in this Recall
0006-0575-82Product
0006-0575-61Product
0006-0575-62Product
0006-0575-01Product
0006-0575-52Product
0006-0575-56Product
0006-0575-02Product
0006-0575-03Product
0006-0577-61Product
0006-0577-62Product
0006-0577-82Product
0006-0577-01Product
0006-0577-52Product
0006-0577-56Product
0006-0577-02Product
0006-0577-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
