D-0002-2025 Class III Ongoing
FDA drug recall D-0002-2025 was initiated by Glenmark Pharmaceuticals Inc., USA on Sep 30, 2024 and is designated Class III. Reason for recall: Defective Container: Firm received complaints of broken tube at the seal. The recall status is ongoing. Affected quantity: 11,568 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 9, 2024
- Initiation Date
- Sep 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,568 tubes
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.
Reason for Recall
Defective Container: Firm received complaints of broken tube at the seal.
Distribution Pattern
Nationwide in the US.
Code Information
Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0002-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026