November 10, 2017
Teva Pharmaceuticals USA is recalling 140,993 bottles of dutasteride and tamsulosin hydrochloride capsules, 0.5 mg/0.4 mg, after product testing produced out-of-specification dissolution results, according to the November 8, 2017, US Food and Drug Administration (FDA) Enforcement Report.
The capsules were manufactured by Actavis Laboratories FL Inc. and were distributed across the United States and in Puerto Rico by Actavis Pharma Inc.
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The recall affects 30-count bottles (NDC 0591-3771-30) from lots 1089376A, 1089382A, 1095210M, 1117768M, and 1117769A (Exp. 11/17), and 1128452A, 1128453A, 1137658A, 1154207A, and 1156087A (Exp. 3/18).
Also recalled are 90-count bottles (NDC 0591-3771-19) from lots 1089379A, 1091533M, and 1125206A (Exp. 11/17), and 1128456A, 1147665A, 1154208A, and 1156088A (Exp. 3/18).
Teva Pharmaceuticals USA initiated the voluntary recall October 25, 2017. On November 2, 2017, the FDA designated it Class II, indicating use of the capsules could cause temporary or reversible adverse effects. However, the probability of serious harm is small.
Dutasteride and tamsulosin hydrochloride capsules are a prescription medication indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
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