Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: LOVASTATIN, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: AD28349_1, EXP: 2/28/2014; FLUVASTATIN SODIUM, Capsule, 20 mg, NDC 00078017615, Pedigree: AD73597_7, EXP: 5/31/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: W003247, EXP: 6/17/2014.
LOVASTATIN, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185007201.
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 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.
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