Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manu
Summary
The FDA issued a Class II for Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed b by Rubicon Research Private Limited. Reason: Presence of Foreign Substance: metal in tablet.
Details
Source
Drug Recall
External ID
D-0517-2024
Action Date
2024-06-05
Status
Ongoing
Category
drug
Product Description
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Lot/Code Info: Lot 231037H1, exp 6/2027
Quantity Affected: 11,664 Bottles
Reason for Recall
Presence of Foreign Substance: metal in tablet
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-06
Company
Ambarnath
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 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Rubicon Research Private Limited has 4 FDA actions in our database, including 4 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 (Rubicon Research Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rubicon Research Private Limited have FDA actions?
Rubicon Research Private Limited has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0517-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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