Calcium Channel Blocker Recalled

Valeant Pharmaceuticals North America LLC is recalling various strengths of Cardizem CD (diltiazem hydrochloride) capsules because tested samples failed to meet dissolution specifications, according to the February 20, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States and in Puerto Rico: 

• 180-mg Cardizem CD capsules in 30-count bottles (NDC 0187-0796-30) from lot 18J018P (Exp. 8/20) and in 90-count bottles (NDC 0187-0796-42) from lot 18J029P (Exp. 8/20);
• 240-mg Cardizem CD capsules in 30-count bottles (NDC 0187-0797-30) from lot 18J019P (Exp. 8/20) and in 90-count bottles (NDC 0187-0797-42) from lot 18J028P (Exp. 8/20); and
• 300-mg Cardizem CD capsules in 30-count bottles (NDC 0187-0798-30) from lot 18J020P (Exp. 8/20) and in 90-count bottles (NDC 0187-0798-42) from lot 18J034P (Exp. 8/20).

 Valeant Pharmaceuticals voluntarily initiated the recall January 30, 2019. On February 14, 2019, the FDA designated it Class III, suggesting use of the recalled capsules is not likely to cause harm. 

Cardizem CD is a prescription calcium channel blocker used to treat patients with hypertension and chest pain. 

—Jolynn Tumolo