February 22, 2019
Valeant Pharmaceuticals North America LLC is recalling 23,884 bottles of diltiazem hydrochloride CD capsules, 360 mg, because samples failed to meet dissolution specifications during routine testing, according to the February 20, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 90-count bottles (NDC 68682-521-01) manufactured by Valeant Pharmaceuticals for its Oceanside Pharmaceuticals division from lots 18J035P, 18K094P, and 18K093P, which have an expiration date of September 2020. The recalled bottles were distributed in the United States and in Puerto Rico.
Valeant Pharmaceuticals voluntarily initiated the recall January 30, 2019. The FDA designated it Class III on February 14, 2019. Under the recall classification, use of the affected capsules is not likely to cause harm.
Diltiazem hydrochloride controlled-delivery is a prescription calcium channel blocker used to treat patients with hypertension and chest pain.