Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules, a medication used to treat high blood pressure in the American market due to failed dissolution specifications, informed USFDA in its latest Enforcement Report.
The affected lot has been produced in India and is being recalled for “failed dissolution specifications”, the USFDA said.
“Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study,” it noted.
Glenmark initiated Class II recall of the drug across the US on March 26 this year.
As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.