Exact FDA event identifier

Event 77800

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

Event summary

Timeline bucket: July 19, 2017
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

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

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

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12

D-1094-2017

Recall number: D-1094-2017
Initiated: July 19, 2017
Classification: Class III
Status: Terminated
Recalling firm: AVKARE Inc.
Quantity: 1172 cartons (23440 tablets)

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/degradation specifications: Out of specification for a related compound C.

Code information

Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018

Distribution pattern

Nationwide