July 2012 FDA Recall Drug by Island Kinetics Dba Covalence
D-1670-2012 - Microbial Contamination of Non Sterile Product; mold

This Class II drug recall was voluntarily initiated by Island Kinetics Dba Covalence on July 13, 2012 for the product Drug. The FDA reported the reason for recall as microbial contamination of non sterile product; mold. The product was distributed in Atlanta, Georgia and the recall is currently terminated.

Recall Number: D-1670-2012

Reason for Recall
Microbial Contamination of Non Sterile Product; mold
Initiated
07-13-2012
Reported
09-05-2012
Quantity
5311 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62779
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Island Kinetics dba Covalence
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Atlanta, Georgia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-18-2013
Product Description About Product Description
Full technical description of the product.
CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.

Batch or Lot Expiration Information

Batch# P030911C, Exp 03/13
Batch# P022811A, Exp 02/13.