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 Son
Recalled August 31, 2016 · FDA recall D-1464-2016 · Stratus Pharmaceuticals
Hazard
Crystallization; Complaints that cream appears to have crystallized · FDA Class III
Units
a) 12,345 tubes; b) 8,578 tubes
Sold at
Nationwide and PR
Description
Crystallization; Complaints that cream appears to have crystallized
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.
Manufacturer(s)
Stratus Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →