Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sampl
Summary
The FDA issued a Class II for Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, by MERCK SHARP & DOHME CORP. Reason: Presence of foreign substance: Presence of stainless steel particulates in tablets..
Details
Source
Drug Recall
External ID
D-0746-2022
Action Date
2022-04-13
Status
Terminated
Category
drug
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/Code Info: Lot: U015824, Exp. 09/22.
Quantity Affected: 3600 cartons
Reason for Recall
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-31
Company
Whitehouse Station, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
MERCK SHARP & DOHME CORP has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MERCK SHARP & DOHME CORP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MERCK SHARP & DOHME CORP have FDA actions?
MERCK SHARP & DOHME CORP has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0746-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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