Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905
Summary
The FDA issued a Class III for Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av by AvKARE. Reason: Failed Impurity/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0528-2025
Action Date
2025-07-09
Status
Ongoing
Category
drug
Product Description
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Lot/Code Info: Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
Quantity Affected: 1,560 bottles
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-26
Company
Pulaski, TN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AvKARE has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AvKARE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AvKARE have FDA actions?
AvKARE has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0528-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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