FDA (Drugs) recall action 95660
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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.
Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.