November 06, 2020
Boehringer Ingelheim Pharmaceuticals Inc. is voluntarily recalling seven lots of Catapres (clonidine hydrochloride) tablets. According to the November 4, 2020, US Food and Drug Administration (FDA) Enforcement Report, an extraneous peak occurred during dissolution testing.
The recall affects the following products, which were distributed throughout the United States and in Puerto Rico:
- 0.1-mg Catapres tablets in 100-count bottles (NDC 0597-0006-01) from lots 761544 (Exp. 1/21), 859015 (Exp. 1/21), 861346 (Exp. 1/22), and 956626, (Exp. 1/22);
- 0.2-mg Catapres tablets in 100-count bottles (NDC 0597-0007-01) from lots 861135 (Exp. 11/21) and C34139 (Exp. 11/21); and
- 0.3-mg Catapres tablets in 100-count bottles (NDC 0597-0011-01) from lot 954953 (Exp. 1/22).
Boehringer Ingelheim Pharmaceuticals initiated the recalls October 5, 2020. The FDA designated them Class II on October 26, 2020, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Catapres tablets are available with a prescription for the treatment of hypertension.