Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
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 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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