Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
National Drug Code
Is NDC 0378-5220-01 recalled?
Diltiazem HCl Extended-Release Capsules
Yes — this exact package was recalled
2 FDA recalls name the code 0378-5220-01 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.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications: OOS results for known compound.
Class III · Low risk
Diltiazem HCl Extended Release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
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.
Other recalled products from this labeler
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