Safety Alerts & Recalls

What does this mean?

iGuard is currently monitoring safety alerts for isotretinoin, also sold as the branded names Sotret, Accutane, Amnesteem, and Claravis. This safety alert involves isotretinoin capsules sold under the name Sotret. Although these recalled capsules are not likely to cause any health problems, you should still check your prescription for the following: 1) Your prescription is labeled "Sotret Isotretinoin Capsules, 40 mg," 2) The prescription is labeled with the manufacturer (Mfg) as Ranbaxy Laboratories and the NDC # 10631-586-77 and 3) The recalled lot number 1876846 can be found on the blister packaging of the capsules. If you think your capsules are involved in the recall or if you are not sure if your capsules are involved, you should return them to your pharmacy to examine and possibly exchange.

Recall of a Single Lot of Sotret Isotretinoin Capsules, 40 mg

Ranbaxy Laboratories is recalling a single lot of Sotret Isotretinoin Capsules, 40 mg (NDC # 10631-586-77), a medication used to treat severe acne. Lot number 1876846, expiration date February 28, 2010 is being recalled because it does not meet manufacturing standards.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-07-10
Last Updated: 2009-12-05

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