D-1464-2016 Class III
FDA drug recall D-1464-2016 was initiated by Stratus Pharmaceuticals Inc on May 26, 2016 and is designated Class III. Reason for recall: Crystallization; Complaints that cream appears to have crystallized Affected quantity: a) 12,345 tubes; b) 8,578 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 31, 2016
- Initiation Date
- May 26, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 12,345 tubes; b) 8,578 tubes
Product 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.
Reason for Recall
Crystallization; Complaints that cream appears to have crystallized
Distribution Pattern
Nationwide and PR
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