Glenmark Pharmaceuticals Inc., USA recalls 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
Recalled October 9, 2024 · FDA recall D-0002-2025 · Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Container: Firm received complaints of broken tube at the seal. · FDA Class III
Units
11,568 tubes
Sold at
Nationwide in the US.
Description
Defective Container: Firm received complaints of broken tube at the seal.
Product
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.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →