Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distribu
Summary
The FDA issued a Class III for Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 by Lannett Company Inc.. Reason: Failed Impurity/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0161-2023
Action Date
2023-01-25
Status
Terminated
Category
drug
Product Description
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
Lot/Code Info: Lots: 21000279A (exp 01/2023), 20256320A (12/2022)
Quantity Affected: 20,040 bottles
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-09
Company
Seymour, IN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lannett Company Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Lannett Company Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lannett Company Inc. have FDA actions?
Lannett Company Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0161-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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