Multi-event September 2012 FDA Recall Drug by Dermacare, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Dermacare, Inc. on September 17, 2012 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-034-2013 TERMINATED D-035-2013 TERMINATED

Recall Number: D-034-2013

Reason for Recall
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Initiated
09-17-2012
Reported
11-07-2012
Quantity
25,956 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63378
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.
DermaCare, 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-01-2014
Product Description About Product Description
Full technical description of the product.
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403

Batch or Lot Expiration Information

Batch# Batch 1782-01059, 2072-01059, and 2082-01195

Recall Number: D-035-2013

Reason for Recall
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Initiated
09-17-2012
Reported
11-07-2012
Quantity
43,272 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63378
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.
DermaCare, 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-01-2014
Product Description About Product Description
Full technical description of the product.
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403

Batch or Lot Expiration Information

Batch# Batch 2082-01085, 1852-01085, 2082-01213, 2152-01261, and 1782-01084