Reported Oct 9, 2024 · 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…
Glenmark Pharmaceuticals Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30 gm Tube, NDC 68462-0455-35 |
| 2 | 45 gm Tube, NDC 68462-0455-47 |
| 3 | 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. |
- Lot codes and dates
Lot #s: a) 19242028Exp. 04/30/2026b) 19242028Exp. 04/30/2026c) 19242028Exp. 04/30/2026
- Amount recalled
- 11,568 tubes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Defective Container: Firm received complaints of broken tube at the seal.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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