FDAClass IIIJanuary 14, 2015

Triamcinolone Acetonide recall: Impurity Out of Spec

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).

Why was Triamcinolone Acetonide recalled?

Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

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?

Lots 1413900, 1417200, 1417300, Exp. 02/15

Product
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Recalling firm
Akorn, Inc.
Quantity
3,937 bottles
Distribution
Nationwide
Recall date
January 14, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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