Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
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.
Reason CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Reason Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Reason Labeling: Label Mixup: LOVASTATIN, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: ASPIRIN EC DR, Tablet, 81 mg…
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