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Severe Acne Treatment Med Recalled


October 17, 2016

The US Food and Drug Administration (FDA) recently reported a nationwide, Class III, recall of isotretinoin capsules USP (Claravis; Teva) 10 mg.

Claravis is a prescription medication used for the treatment of severe recalcitrant nodular acne. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Its isomer, tretinoin, is also an acne drug.

Teva Pharmaceuticals voluntarily initiated the recall in August 2016 due to “failed impurities/degradation specifications,” as described in the FDA report.

The recall is ongoing and affects a total of 3569 capsules. The impacted lot number is 34025714A with a December 2016 expiration date. The product is packaged in a carton containing three 10-capsule Blister Packs.

Meredith Edwards White

 

References

https://www.accessdata.fda.gov/scripts/ires/index.cfm

http://www.fda.gov/Safety/Recalls/ucm165546.htm

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