Recall: D-0528-2025

Class III - Minor Violations

Class IIIClassification

2025-06-26Initiated

OngoingStatus

AvKAREFirm

Product

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

Reason

Failed Impurity/Degradation Specifications

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.