FDA-Drug2014-07-23Class III

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.

Fougera Pharmaceuticals Inc.
Hazard

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

Sold states
Nationwide
Affected count
111,388 Bottles
Manufactured in
60 Baylis Rd, N/A, Melville, NY, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1440-2014

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