FDAClass IIISeptember 2, 2015

Topicort recall: Impurity Out of Spec

Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist…

Why was Topicort recalled?

Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

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 #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016.

Product
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist…
Recalling firm
Taro Pharmaceuticals, Inc.
Quantity
16,320 Bottles
Distribution
U.S. Nationwide
Recall date
September 2, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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