Reported Aug 31, 2016 · Completed
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…
Stratus Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stratus Pharmaceuticals Inc · 12379 SW 130th St · Miami, FL · 33186-6208
Is this the product you have?
- 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.
- Lot codes and dates
- 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
- a) Lot (Exp)
- Amount recalled
- a) 12,345 tubes; b) 8,578 tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
Crystallization; Complaints that cream appears to have crystallized
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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