Safety Alerts & Recalls

What does this mean?

This recall for Fluocinonide Ointment USP, 0.05% from Nycomed US, Inc. was issued at a warehouse/pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you use fluocinonide Ointment USP, 0.05% and are concerned, you should follow up with your physician or pharmacist.

Nycomed US, Inc. Recalls select lots of Fluocinonide Ointment USP, 0.05%

Nycomed US, Inc. is recalling select lots of Fluocinonide Ointment USP, 0.05%, 15 gram, 30 gram, and 60 gram tubes, for external use only. The following lots and expiration dates (exp) are being recalled as a precaution because samples from a previous batch did not pass the manufacturer's routine tests for the acceptable amount of by-products from chemical breakdown over time: Fluocinonide Ointment USP, 0.05%, 15 grams: batch 902A (exp 9/11)

Fluocinonide Ointment USP, 0.05%, 30 grams: batch 982A (exp 10/11)

Fluocinonide Ointment USP, 0.05%, 60 grams: batch 111B (exp 10/11)

The following lot and expiration date (exp) is being recalled because of reports of leakage from the tube crimp: Fluocinonide Ointment USP, 0.05%, 30 grams: batch 872A (exp 9/11)

Fluocinonide ointment is applied to the skin for the treatment of a variety of skin conditions. This recall alert only applies to select lots of Fluocinonide Ointment USP, 0.05% made by Nycomed US, Inc. No other fluocinonide products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here and

more information here

Source: FDA
Publication Date: 2010-04-12
Last Updated: 2010-04-13

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