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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71646

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

Open FDA event record

Event summary

Timeline bucket
June 29, 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

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

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

D-1239-2015
Recall number
D-1239-2015
Initiated
June 29, 2015
Classification
Class III
Status
Terminated
Recalling firm
Qualitest Pharmaceuticals
Quantity
47,376 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Code information

100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 0603-3968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16

Distribution pattern

Nationwide