FDA Drug recall 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, Carl…
- FDA Drug
- Class III
- completed
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class III recall of 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, Carl… by Stratus Pharmaceuticals, citing crystallization; Complaints that cream appears to have crystallized.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1464-2016 |
| Classification | Class III |
| Status | completed |
| Initiated | 2016-05-26 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Stratus Pharmaceuticals |
| Distribution | US |
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
Crystallization; Complaints that cream appears to have crystallized
Identifiers
| code_info | 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),…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1464-2016%22
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