FDAClass IIIJuly 23, 2014

Triamcinolone Acetonide recall

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…

Why was Triamcinolone Acetonide recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Fougera Pharmaceuticals Inc.
Quantity
111,388 Bottles
Distribution
Nationwide
Recall date
July 23, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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