Recall D-0002-2025

US Class III Ongoing · initiated 2024-09-30

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

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.

Reason for recall

Defective Container: Firm received complaints of broken tube at the seal.

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