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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74519

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

Open FDA event record

Event summary

Timeline bucket
May 26, 2016
Product types
Drug
Classifications
Class III
Statuses
Completed
Recalling firm wording
Stratus Pharmaceuticals 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

Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.

D-1464-2016
Recall number
D-1464-2016
Initiated
May 26, 2016
Classification
Class III
Status
Completed
Quantity
a) 12,345 tubes; b) 8,578 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization; Complaints that cream appears to have crystallized

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization; Complaints that cream appears to have crystallized

Code information

a) Lot (Exp): 8020 (02/17), 8096 (07/18), 8125 (08/18), 8169 (10/18). NDC 58980-680-50 b) Lot (Exp): 8020 (02/17), 8125 (08/18), 8170 (10/18). NDC 58980-680-90

Distribution pattern

Nationwide and PR