FDA recall D-1441-2014

Product

Triamcinolone Acetonide Lotion USP, 0.025%, 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 0168-0336-60.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-03

Report date

2014-07-23

Termination date

2015-12-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1441-2014