Exact FDA event identifier

Event 71776

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

Event summary

Timeline bucket: July 20, 2015
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Qualitest Pharmaceuticals

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

ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28

D-1405-2015

Recall number: D-1405-2015
Initiated: July 20, 2015
Classification: Class III
Status: Terminated
Recalling firm: Qualitest Pharmaceuticals
Quantity: 21552 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Code information

CP0761501, Exp. 12/16

Distribution pattern

Nationwide and PR