Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark…
Reason CGMP Deviations
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
What was recalled
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-5280-01
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0506-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Diltiazem recalls
See all
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for…
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for…
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for…
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals…
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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