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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stratus Pharmaceuticals Inc
- Reason for Recall:
- Crystallization; Complaints that cream appears to have crystallized
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1464-2016