Recall events
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Event 97160
Event summary
Timeline bucket June 26, 2025
Product types Drug
Classifications Class III
Statuses Ongoing
Recalling firm wording AvKARE
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
2 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 2
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
D-0528-2025
Recall number D-0528-2025
Initiated June 26, 2025
Classification Class III
Status Ongoing
Quantity 1,560 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Impurity/Degradation Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurity/Degradation Specifications
Code information Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16812]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
D-0529-2025
Recall number D-0529-2025
Initiated June 26, 2025
Classification Class III
Status Ongoing
Quantity 8,573 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Impurity/Degradation Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurity/Degradation Specifications
Code information Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15600]
FDA event record
· Exact recall-number query on openFDA
