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Recall Observatory FDA recall evidence

Drug product

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.

D-1440-2014

July 03, 2014

Class III

Product summary

Firm
Fougera Pharmaceuticals Inc.
Event
Event 68683
Status
Terminated
Classification
Class III
Quantity
111,388 Bottles
Official record key
drug-enforcement:D-1440-2014

Official wording

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

Code information: Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    may not meet specification