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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74744

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

Open FDA event record

Event summary

Timeline bucket
June 02, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Exact-Rx 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

Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY

D-1465-2016
Recall number
D-1465-2016
Initiated
June 02, 2016
Classification
Class III
Status
Terminated
Recalling firm
Exact-Rx Inc
Quantity
6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization; complaints received by the manufacturer of crystals forming in product

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization; complaints received by the manufacturer of crystals forming in product

Code information

Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018

Distribution pattern

Nationwide