Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications
AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a labeling or manufacturing defect where the hazard is theoretical and no illnesses or injuries have been reported. Class III recalls are by definition unlikely to cause adverse health consequences.
Plain-English summary
AvKARE is recalling Pitavastatin Tablets, 2 mg (90 tablets per bottle), manufactured for AvKARE in Pulaski, Tennessee. The recall affects three lots: Lot 46211 (expiration 10/31/2025), Lot 47683 (expiration 05/31/2026), and Lot 46944 (expiration 01/31/2026), representing approximately 8,573 bottles distributed nationwide in the USA.
The recall is due to failed impurity and degradation specifications, meaning the tablets do not meet established quality standards for chemical purity and stability. Pitavastatin is a prescription medication used to lower cholesterol.
Patients currently taking Pitavastatin from the affected lots should contact their pharmacist or healthcare provider. Do not stop taking the medication without medical guidance. Healthcare providers and pharmacists should quarantine and return affected inventory to AvKARE.
The recalled product
- Product
- PITAVASTATIN (PITAVASTATIN CALCIUM)
- Brand
- PITAVASTATIN
- Manufacturer
- AvKARE
- Category
- Drug — Prescription - Statin
- Hazard
- impurity
- degradation
- quality-control
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot
- expiry: Lot 46211
- exp 10/31/2025
- Lot 47683
- exp 05/31/2026
- Lot 46944
- exp 01/31/2026
Distribution
Distributed nationwide across the United States.
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