FDA Class III Recall of Osteoporosis Med

The US Food and Drug Administration (FDA) announced the ongoing, Class III recall of 25,916 cartons of once-a-week risedronate sodium delayed-release tablets, 35 mg, in its latest Enforcement Report.

The medication, which is used for the treatment of osteoporosis in women who are postmenopausal, was recalled throughout the United States and Puerto Rico because of “low out of specification dissolution results found during stability testing,” the FDA report states.
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The recalled product is packaged in 4 blisters per carton (with each blister containing 1 tablet) and is from lot number 34025762A (expiration date 06/17).

The recall was voluntarily initiated by Teva Pharmaceuticals USA last month, and the FDA gave the recall a Class III designation earlier this month.

—Meredith Edwards White