Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Defective Container: Firm received complaints of broken tube at the seal.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Reason Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Reason Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
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