Stratus Pharmaceuticals Recalls Remeven Cream Due to Crystallization
Stratus Pharmaceuticals is recalling Remeven Cream because the product has crystallized. The recall covers specific lots of 5.0 oz and 9.0 oz tubes.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (crystallization) with no reported injuries.
Plain-English summary
Stratus Pharmaceuticals Inc. is recalling Remeven Cream, a prescription-only medication containing 50% Urea in a Cream Base. The recall affects 5.0 oz (142 g) and 9.0 oz (255 g) tubes manufactured by Sonar Products Inc. and distributed by Stratus Pharmaceuticals Inc.
The recall was initiated due to complaints that the cream appears to have crystallized. The affected products include specific lots with expiration dates ranging from February 2017 to October 2018. The distribution pattern is nationwide and Puerto Rico.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Stratus Pharmaceuticals Inc
- Category
- Drug — Topical Cream
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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)
- 8170 (10/18). NDC 58980-680-90
Distribution
Distributed nationwide across the United States.
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