Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; M
Summary
The FDA issued a Class II for Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distribute by Rubicon Research Private Limited. Reason: Complaint received of foreign matter (metal) embedded in tablet..
Details
Source
Drug Recall
External ID
D-0362-2022
Action Date
2022-01-19
Status
Terminated
Category
drug
Product Description
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
Lot/Code Info: Batch # 210211H1, Exp. date FEB 2024
Quantity Affected: 3,684 1000-count bottles
Reason for Recall
Complaint received of foreign matter (metal) embedded in tablet.
Distribution
Product was distributed to one distributor who may have distributed the product further nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-31
Company
Ambernath, N/A
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 66 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-0362-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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