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Recall Observatory FDA recall evidence

Drug product

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3

D-0790-2017

March 17, 2017

Class III

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 76837
Status
Terminated
Classification
Class III
Quantity
7,776 tubes
Official record key
drug-enforcement:D-0790-2017

Official wording

Reason: Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.

Code information: Lot #: D301311473, D301411473, Exp 3/2017

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.