D-0528-2025 Class III Ongoing
FDA drug recall D-0528-2025 was initiated by AvKARE on June 26, 2025 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specifications The recall status is ongoing. Affected quantity: 1,560 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2025
- Initiation Date
- June 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,560 bottles
Product Description
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;