Safety Alerts & Recalls

What does this mean?

This recall for Claravis (isotretinoin), 40 mg capsules from Teva Pharmaceuticals USA, Inc. 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. If you take Claravis (isotretinoin), 40 mg capsules and are concerned, you should speak to your doctor.

Teva Recalls a Single Lot of Claravis Capsules

Teva Pharmaceuticals USA Inc. have recalled a single lot of Claravis (isotretinoin), 40 mg capsules. Lot number 701980 has been recalled because this lot failed the manufacturer routine 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 sold under other brand names. This recall alert only applies to the single lot of Claravis (isotretinoin), 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: 2010-10-27
Last Updated: 2010-10-29

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