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Recall Observatory FDA recall evidence

Drug product

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

May 26, 2016

Class III

Product summary

Firm
Stratus Pharmaceuticals Inc
Event
Event 74519
Status
Completed
Classification
Class III
Quantity
a) 12,345 tubes; b) 8,578 tubes
Official record key
drug-enforcement:D-1464-2016

Official wording

Reason: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization; Complaints that cream appears to have crystallized