Prostate Drug Recalled

Ascend Laboratories is recalling 3072 bottles of tamsulosin hydrochloride capsules, 0.4 mg,

because samples failed to meet dissolution specifications during routine testing, according to the March 13, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 500-count bottles (NDC 67877-450-05) manufactured by Alkem Laboratories and distributed throughout the United States and in Puerto Rico by Ascend Laboratories. The recalled bottles are from lot 8144652 (Exp. 7/20).

Ascend Laboratories voluntarily initiated the recall February 22, 2019. At press time, the FDA had not yet issued a recall classification.

Tamsulosin hydrochloride is a prescription alpha-blocker used to treat benign prostatic hyperplasia. 

—Jolynn Tumolo