January 24, 2020
Sun Pharmaceutical Industries Inc. has recalled multiple drugs this week*. First the firm is recalling sumatriptan succinate tablets in bottles and blister packs after medication samples failed to meet impurity/degradation specifications during routine testing, according to the January 22, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were sent to distributors and repackagers throughout the United States:
- sumatriptan succinate tablets, 50 mg, packaged in one-tablet blister packs, nine packs per carton (NDC 62756-521-69), from lots JKU1939A, JKU1940A, and JKU1940B (Exp. 4/22);
- sumatriptan succinate tablets, 50 mg, packaged in 100-count bottles (NDC 62756-521-88) from lot JKT4175A (Exp. 11/20); and
- sumatriptan succinate tablets, 100 mg, packaged in one-tablet blister packs, nine packs per carton (the FDA did not list an NDC code in the report), from lots JKT4174A (Exp. 11/21), JKU0622A (Exp. 1/22), and JKU1308A (Exp. 2/22).
Sun Pharmaceutical Industries voluntarily initiated the recall December 26, 2019. On January 13, 2020, the FDA designated the recall Class II, communicating use of the tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Sumatriptan is a prescription selective serotonin receptor agonist used to treat migraine and cluster headaches.