May 2016 FDA Recall Drug by Stratus Pharmaceuticals Inc
D-1464-2016 - Crystallization; Complaints that cream appears to have crystallized

This Class III drug recall was voluntarily initiated by Stratus Pharmaceuticals Inc on May 26, 2016 for the product Drug. The FDA reported the reason for recall as crystallization; complaints that cream appears to have crystallized. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-1464-2016

Reason for Recall
Crystallization; Complaints that cream appears to have crystallized
Initiated
05-26-2016
Reported
08-31-2016
Quantity
a) 12,345 tubes; b) 8,578 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74519
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Stratus Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and PR
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# 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