December 10, 2020
Ascend Laboratories is voluntarily recalling a single lot of tizanidine tablets because samples failed to meet dissolution specifications during routine testing, according to the December 9, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 4-mg tizanidine tablets packaged in 150-count bottles (NDC 67877-614-15) from lot 19143017 (Exp. 5/31/21). The tablets were manufactured by Alkem Laboratories and distributed by Ascend Laboratories in Michigan.
Ascend Laboratories initiated the recall November 24, 2020. At press time, the FDA had not yet classified the recall.
Tizanidine is a prescription muscle relaxant indicated for the management of spasticity.