Migraine Drug Recalled

More than a half million blister packs of rizatriptan are being recalled by Macleods Pharma USA Inc. The voluntary recall was prompted by “out-of-specification test results obtained in organic impurities test during analysis of controlled samples,” according to the November 3, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following rizatriptan products, which were distributed throughout the United States:

• rizatriptan benzoate film-coated tablets, 10 mg, 12 tablets (NDC 33342-088-45) and 18 tablets (NDC 33342-088-41), from lots BRJ2112A, BRJ2113A, BRJ2114A, and BRJ2114B (Exp. 4/24);
• rizatriptan benzoate orally disintegrating tablets 5 mg, 12 tablets (NDC 33342-093-41), from lots BRL2102A and BRL2103A (Exp. 4/25); and
• rizatriptan benzoate orally disintegrating tablets 10 mg, 18 tablets (NDC 33342-094-41), from lots BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, and BRM2116A (Exp. 4/25).

The recalled tablets were manufactured by Macleods Pharmaceuticals Ltd, Baddi, Himachal Pradesh, India, for Macleods Pharma USA, Plainsboro, NJ. Macleods Pharma USA voluntarily initiated the recall October 18, 2021. On October 28, 2021, the FDA designated the recall Class III, suggesting use of the recalled drugs is not likely to cause harm.

Rizatriptan is a prescription drug used to treat migraines.