Class III
Ongoing
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.
This recall is currently active, issued October 9, 2024. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- September 30, 2024
- Posted
- October 9, 2024
- Recall Number
- D-0002-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,568 tubes
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Container: Firm received complaints of broken tube at the seal.
Distribution
Nationwide in the US.
Lot / Code Info
Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
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