FDA recall D-1464-2016

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.

Reason for recall

Crystallization; Complaints that cream appears to have crystallized

Distribution

Nationwide and PR

Key facts

Status

Completed

Initiation date

2016-05-26

Report date

2016-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1464-2016