Drug Enforcement D-0528-2025

Failed Impurity/Degradation Specifications

Status

Ongoing

Classification

Class III

Report Date

July 9, 2025

Termination Date

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Product Information

Product description
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Product quantity
1,560 bottles
Reason for recall
Failed Impurity/Degradation Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0528-2025
Event ID
97160
Recall initiation date
June 26, 2025
Center classification date
July 16, 2025
Code info
Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
More code info
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