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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82296

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 01, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
AVKARE Inc.

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

Complete imported group

Every recalled product in this event

1 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 1

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

D-0990-2019
Recall number
D-0990-2019
Initiated
March 01, 2019
Classification
Class III
Status
Terminated
Recalling firm
AVKARE Inc.
Quantity
a) 2947 and b) 3379

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020

Distribution pattern

Nationwide.