Stratus Pharmaceuticals Inc recalls 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 Sona…

Recall date

May 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1464-2016

FDA classification

Class III

Brand / firm

Stratus Pharmaceuticals Inc

Sold / distributed

Nationwide and PR

Why it was recalled

Crystallization; Complaints that cream appears to have crystallized

Class III means the product violates regulations but is not likely to cause harm.

What 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.