Calcium Channel Blocker Pulled

Mylan Pharmaceuticals Inc. is recalling more than 12,000 bottles of diltiazem hydrochloride extended-release capsules, USP, 120 mg, because of out-of-specification results during routine stability testing.

According to the September 19, 2018, US Food and Drug Administration (FDA) Enforcement Report, the recall affects 100-count bottles (NDC 0378-5220-01) and 500-count bottles (NDC 0378-5220-05) from batch 3093163 (Exp. 4/19). The bottles were distributed throughout the United States.

Mylan Pharmaceuticals voluntarily initiated the recall August 7, 2018. On September 10, 2018, the FDA designated the recall Class III, signaling use of the recalled drugs is not likely to cause harm.

Diltiazem hydrochloride is a prescription calcium channel blocker used for the treatment of high blood pressure, chest pain, and some heart rhythm disorders.

—Jolynn Tumolo

For more Pharmacy Learning Network articles, visit the homepage

To learn about Pharmacy Learning Network Live meetings, click here