Recall
FDAHealthJune 26, 2025

AvKARE — Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

⚠️ Failed Impurity/Degradation Specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 26, 2025

Nationwide in the USA

What's affected?

Product
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Lot code
46211

Additional details

Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 8,573 bottles.

View original FDA notice →

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