Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.

Recall Number: D-1440-2014

Firm: Fougera Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20140723

Initiation Date: 20140703

Termination Date: 20151207

Reason for Recall

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Product Description

Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.