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 III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDCs
68001-0316-00
68001-0316-08
Compare with the code on your package — it is the most precise check available.
Drug: Lovastatin Category: Cholesterol Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lovastatin NDC 68001-0316 |
40 mg/1 | Tablet Oral |
BluePoint Laboratories | Rx |
- Recalling firm
- American Health Packaging
- NDC code
- 68001-316-00
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1584-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 II · Moderate risk
Lovastatin Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
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 American Health Packaging
All 2019 recalls
Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
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