Migraine Tablets Pulled
Glenmark Pharmaceuticals Inc. USA is recalling 10 lots of rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating tablets because of an N-nitroso desmethyl rizatriptan impurity, according to the June 12, 2024, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured in India for Glenmark Pharmaceuticals USA, Mahwah, New Jersey, and distributed throughout the United States:
- rizatriptan benzoate tablets, 5 mg, 18 (3 x 6) unit-dose tablets (NDC 68462-465-99), from lots 19233788 (Exp. 9/25) and 19224445 (Exp. 9/24);
- rizatriptan benzoate tablets, 10 mg, 18 (3 x 6) unit-dose tablets (NDC 68462-466-99), from lots 19224217 (Exp. 9/24), 19233789 (Exp. 9/25), and 19224444 (Exp. 9/24);
- rizatriptan benzoate orally disintegrating tablets, 5 mg, 18 (3 x 6) unit-dose tablets (NDC 68462-467-06), from lots 19224857 (Exp. 11/24) and 19232493 (Exp. 6/25); and
- rizatriptan benzoate orally disintegrating tablets, 10 mg, 18 (3 x 6) unit-dose tablets (NDC 68462-468-06), from lots 19223402 (Exp. 6/24), 19224858 (Exp. 11/24), and 19232492 (Exp. 6/25).
Glenmark Pharmaceuticals USA voluntarily initiated the recall for rizatriptan benzoate tablets on May 10, 2024, and for rizatriptan benzoate orally disintegrating tablets on May 13, 2024. The FDA designated the recalls Class II on June 4, 2024. The designation communicates that use of the recalled tablets may cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Rizatriptan benzoate is a prescription drug indicated for the acute treatment of migraine in adults and pediatric patients 6 years and older.
