Safety Alerts & Recalls

What does this mean?

This recall for Tretinoin Cream from Ortho Pharmaceutical Division of Janssen Ortho LLC was issued at a warehouse and 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. However, if you use Tretinoin cream and notice that you are responding differently to your medicine, please check to see if your Tretinoin is labeled with one of the recalled lot numbers 9AM459, 9DM626, and 9EM634. If you think your Tretinoin is involved in the recall or if you have concerns about your response to your medicine, please follow up with your doctor or pharmacist.

Tretinoin Cream: Three lots recalled by Ortho Pharmaceutical

Ortho Pharmaceutical Division of Janssen Ortho LLC is recalling three lots of Tretinoin Cream, 0.025% in 20 gram tubes. Lot number 9AM459, 9DM626, and 9EM634 are being recalled because because of a labeling mix-up. Tretinoin Cream 0.025% was packaged in tubes labeled as Tretinoin Cream 0.1%.

Tretinoin Cream is applied to the skin in the treatment of severe acne and to reduce fine wrinkles and rough skin patches of the face. Tretinoin is available in other formulations such as capsules and is sold under many different brand names. No other lots, strengths, formulations or brands of tretinoin were involved in this recall.

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

Source: FDA
Publication Date: 2010-07-20
Last Updated: 2010-07-22

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