Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 g
Summary
The FDA issued a Class III for Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a by Glenmark Pharmaceuticals Inc., USA. Reason: Defective Container: Firm received complaints of broken tube at the seal..
Details
Source
Drug Recall
External ID
D-0002-2025
Action Date
2024-10-09
Status
Ongoing
Category
drug
Product Description
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Lot/Code Info: Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
Quantity Affected: 11,568 tubes
Reason for Recall
Defective Container: Firm received complaints of broken tube at the seal.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-30
Company
Mahwah, 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 29 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 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 (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0002-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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