Class III · Low risk Terminated
Lovastatin Tablets USP
Reason CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Lovastatin Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
What was recalled
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
- Recalling firm
- AVKARE Inc.
- NDC code
- 50268-512-15
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0222-2018
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.
Other Lovastatin recalls
See all
Class III · Low risk Terminated
Lovastatin Tablets USP
Reason CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class II · Moderate risk Terminated
Lovastatin
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, 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.
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