FDA-Drug2016-08-31Class III
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.
Stratus Pharmaceuticals Inc
Hazard
Crystallization; Complaints that cream appears to have crystallized
Sold states
Nationwide and PR
Affected count
a) 12,345 tubes; b) 8,578 tubes
Manufactured in
12379 SW 130th St, Miami, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1464-2016Don't want to check this manually?
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