FDAHealthJune 26, 2025
AvKARE — Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
⚠️ 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, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
- Brand
- PITAVASTATIN
- Lot code
- 46208
Additional details
Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 1,560 bottles.
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