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…

Recall date

September 30, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0002-2025

FDA classification

Class III

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide in the US.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.