Class III · Low risk
Lovastatin Tablets USP
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.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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.
Affected NDC
50268-0512-15
Compare with the code on your package — it is the most precise check available.
Drug: Lovastatin Category: Cholesterol Medication
- Recalling firm
- AVKARE Inc.
- NDC code
- 50268-512-15
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0222-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lovastatin recalls
See all
Class III · Low risk
Lovastatin Tablets USP
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class II · Moderate risk
Lovastatin
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.
Other recalls by AVKARE Inc.
All 2018 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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