Safety Alerts & Recalls

What does this mean?

This recall for Claravis (isotretinoin) 40 mg capsules 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 take Claravis (isotretinoin) 40 mg capsules and are concerned, you should consult with your doctor.

Recall of a Single Lot of Claravis (isotretinoin) capsules, 40 mg

Teva Pharmaceuticals is recalling of a single lot of Claravis (isotretinoin) 40 mg capsules made by Barr Laboratories. Lot number 312733 is being recalled because this lot failed the routine manufacturer tests that measure the capsules' ability to dissolve.

Claravis contains the active ingredient isotretinoin and is commonly used in the treatment of severe acne. Isotretinoin is also known by the the brand names Accutane, Amnesteem and Sotret. This recall alert only applies to the single lot of Claravis 40 mg capsules. No other isotretinoin products were involved in this recall.

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

Source: FDA
Publication Date: 2010-03-31
Last Updated: 2010-04-02

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