FDA-Drug2024-10-09Class III
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.
Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Container: Firm received complaints of broken tube at the seal.
Sold states
Nationwide in the US.
Affected count
11,568 tubes
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2025Don't want to check this manually?
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