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.

FDA recall notice · announced August 31, 2016 · Stratus Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide and PR
Lot/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
Quantity: a) 12,345 tubes; b) 8,578 tubes
Status: Completed
Products in this recall event:
- 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 (D-1464-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.