KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceut...
FDA Recall #D-1044-2014 — Class III — November 18, 2013
Product Description
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Recalling Firm
Fougera Pharmaceuticals Inc. — Melville, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
31,122 tubes
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 495P, Exp 07/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated