Overactive Bladder Drug Recalled

Two firms have voluntarily issued recalls for 10-mg oxybutynin chloride extended-release tablets because samples failed to meet dissolution specifications during routine testing, according to the March 20, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

Lannett Company Inc. is recalling 14,448 bottles, each containing 100 tablets (NDC 62175-271-37), from lots 18226783A (Exp. 7/21) and 18232540A (Exp. 8/21). The recalled bottles were distributed throughout the United States and in Puerto Rico. 

AvKARE is recalling 2947 bottles, each containing 100 tablets (NDC 42291-634-01), from lot 22738 (Exp. 7/20). The company is also recalling 3379 bottles of 500 tablets each (NDC 42291-634-50) from lot 22739 (Exp. 7/20). The recalled bottles were distributed throughout the United States. 

The recalls have been designated Class III by the FDA, suggesting use of the affected tablets is not likely to cause adverse health consequences. The designation was issued in mid-March, following a recall initiation by Lannett Company on February 21, 2019, and by AvKARE on March 1, 2019. 

Oxybutynin chloride is a prescription antispasmodic and anticholinergic medication used to treat frequent, urgent urination, urine leakage, and other symptoms of overactive bladder. 

—Jolynn Tumolo