Recalls / Class III
Class IIID-0529-2025
Product
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
- Brand name
- Pitavastatin
- Generic name
- Pitavastatin Calcium
- Active ingredient
- Pitavastatin Calcium
- Route
- Oral
- NDCs
- 42291-905, 42291-906, 42291-907
- FDA application
- ANDA205932
- Affected lot / code info
- Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Why it was recalled
Failed Impurity/Degradation Specifications
Recalling firm
- Firm
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 8,573 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-06-26
- FDA classified
- 2025-07-16
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0529-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.