Drug 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.
D-0002-2025
Product summary
- Event
- Event 95444
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 11,568 tubes
- Official record key
drug-enforcement:D-0002-2025
Official wording
Reason: Defective Container: Firm received complaints of broken tube at the seal.
Code information: Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Unknown
Defective Container: Firm received complaints of broken tube at the seal.