FDAFDA · Food and drugs·Recall number D-1464-2016
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.
Published August 31, 2016 · Recall initiated: May 26, 2016
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization; Complaints that cream appears to have crystallized
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stratus Pharmaceuticals Inc
- Distributor
- Nationwide and PR
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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