Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations
National Drug Code
Diltiazem Hydrochloride · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-562-01)
4 FDA recalls name the code 68462-0562-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
4 of these recalls are still ongoing.
CGMP Deviations
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Failed Dissolution Specifications
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Free recall alerts
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