Mylan has issued a voluntarily Class III recall for more than 100,000 units of clonazepam, its generic version of Roche’s Klonopin (clonazepam), due to an out-of-specification result for clonazepam-related compound A, a known impurity, at a specified time point. Mylan initiated the recall in September 2016, and the recall was noted in the November 16, 2016 US Food and Drug Administration Weekly Enforcement Report.

A Class III recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

The recall applies to clonazepam tablets, USP, 0.5 mg, packaged in (a)100-count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and( b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), prescription only, manufactured by Mylan Pharmaceuticals Inc. in Morgantown, West Virginia. The recall affects 1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each). The out-of-specification result occurred at a 15-month time point.

The recall also applies to clonazepam tablets, USP, 1.0 mg, packaged in a 100-count unit dose box of 10 x 10 blister cards (NDC 51079-882-20), prescription only, manufactured by Mylan Pharmaceuticals Inc. in Morgantown, West Virginia. The recall affects 46,472 unit dose blister cards (10 cards of 10 tablets each). The out-of-specification result for this product occurred at a 16-month time point.

Clonazepam is indicated for treating seizure disorders and panic disorder.

Source: US FDA (0.5 mg dosage) and US FDA (1.0 mg dosage)