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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88091

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

Open FDA event record

Event summary

Timeline bucket
June 09, 2021
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

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

D-0631-2021
Recall number
D-0631-2021
Initiated
June 09, 2021
Classification
Class III
Status
Terminated
Recalling firm
AVKARE Inc.
Quantity
10 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.

Code information

Lot: 38617 Exp. 10/2022

Distribution pattern

Distributed in Los Angeles California