January 24, 2020
AvKare Inc. has initiated a voluntary recall for nearly 4000 cartons of dutasteride capsules. Among other drugs that were recalled this week*, the January 22, 2020 US Food and Drug Administration (FDA) Enforcement Report shows that samples of this medication failed to meet impurity specifications during routine testing.
The recall affects dutasteride capsules, 0.5 mg, 30-capsule cartons (NDC 50268-282-13) from lots 25246 (Exp. 2/21), 24532 (Exp. 10/20), and 23647 (Exp. 6/20). The capsules were distributed throughout the United States.
AvKare initiated the recall January 7, 2020. On January 13, 2020, the FDA designated the recall Class II. Under Class II recalls, use of the recalled medication could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Dutasteride is available with a prescription to treat symptoms of an enlarged prostate.