FDA (Drugs) recall action 79936
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules because stability testing showed high dissolution results, failing specifications.
McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, 240 mg, because stability testing showed high dissolution results.
McKesson Packaging Services is recalling Diltiazem CD 180 mg capsules because stability testing showed high dissolution results.