Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN...
FDA Recall #D-0529-2025 — Class III — June 26, 2025
Product Description
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Reason for Recall
Failed Impurity/Degradation Specifications
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
8,573 bottles
Distribution
Nationwide in the USA
Code Information
Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated