Drug 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.
D-1464-2016
Product summary
- Event
- Event 74519
- Status
- Completed
- Classification
- Class III
- Quantity
- a) 12,345 tubes; b) 8,578 tubes
- Official record key
drug-enforcement:D-1464-2016
Official wording
Reason: Crystallization; Complaints that cream appears to have crystallized
Code information: a) Lot (Exp): 8020 (02/17), 8096 (07/18), 8125 (08/18), 8169 (10/18). NDC 58980-680-50 b) Lot (Exp): 8020 (02/17), 8125 (08/18), 8170 (10/18). NDC 58980-680-90
Distribution pattern: Nationwide and PR
Derived failure modes
-
Unknown
Crystallization; Complaints that cream appears to have crystallized