December 17, 2020
More than 6700 bottles of imatinib mesylate tablets are being recalled due to deviations from good manufacturing practices, according to the December 16, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, manufactured by Shilpa Medicare Limited and distributed throughout the United States by Armas Pharmaceuticals Inc.:
- 100-mg imatinib mesylate tablets in 90-count bottles (NDC 72485-202-90) from lots 7S10033B, 7S10033A, and 7S10031A (Exp. 2/28/21); and
- 400-mg imatinib mesylate tablets in 30-count bottles (NDC 72485-203-30) from lots 7S10032A and 7S10034A (Exp. 2/28/21).
Shilpa Medicare Limited voluntarily initiated the recall November 17, 2020. On December 9, 2020, the FDA designated it Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Imatinib is a chemotherapy medication used to treat leukemia, other cancers, and related diseases.