ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Phar
Summary
The FDA issued a Class III for ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADI by Leading Pharma, LLC. Reason: Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules.
Details
Source
Drug Recall
External ID
D-1546-2022
Action Date
2022-10-05
Status
Terminated
Category
drug
Product Description
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
Lot/Code Info: Lot#: B14221, Exp. Date 02/2023
Quantity Affected: 960 bottles (100 capsules)
Reason for Recall
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-23
Company
Fairfield, NJ
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 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Leading Pharma, LLC has 2 FDA actions in our database, including 2 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 (Leading Pharma, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Leading Pharma, LLC have FDA actions?
Leading Pharma, LLC 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-1546-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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