FDA Drug Low Class III Completed

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.

Reported: August 31, 2016 Initiated: May 26, 2016 #D-1464-2016

Product Description

Reason for Recall

Crystallization; Complaints that cream appears to have crystallized

Details

Recalling Firm: Stratus Pharmaceuticals Inc
Units Affected: a) 12,345 tubes; b) 8,578 tubes
Distribution: Nationwide and PR
Location: Miami, FL

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Stratus Pharmaceuticals Inc. Units affected: a) 12,345 tubes; b) 8,578 tubes.

Why was this product recalled? ▼

Crystallization; Complaints that cream appears to have crystallized

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 31, 2016. Severity: Low. Recall number: D-1464-2016.