December 2012 FDA Recall Drug by Johnson & Johnson (D-098-2013 - Superpotent (Single Ingredient Drug))

This Class III drug recall was voluntarily initiated by Johnson & Johnson on December 4, 2012 for the product Drug. The FDA reported the reason for recall as superpotent (single ingredient drug). The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-098-2013

Reason for Recall
Superpotent (Single Ingredient Drug): salicylic acid
Initiated
12-04-2012
Reported
12-26-2012
Quantity
1,474,462 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63787
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Johnson & Johnson
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.
04-29-2014
Product Description About Product Description
Full technical description of the product.
Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8

Batch or Lot Expiration Information

Lot# 0142VA, 0132VB, 0112VC, 0122VB, 0102VA, 0102VB, 0112VB 0122VA, 0092VB, 0112VA, 0092VA, 0082VA, 0072VA, 0062VA 0062VB, 0052VA, 0052VB, 0042VA, 0032VA, 0022VA, 0012VA, 0171VA, 0171VB, 0161VB, 0151VA, 0161VA, 0141VA, 0131VA 0131VB, 0121VA, 0111VA, 0101VA, 0091VA, 0081VB, 0081VA 0071VA, 0061VA, 0051VB, 0051VA, 0041VA, 0031VA, 0021VB 0011VC, 0011VB, 0190VA, 0011VA, 0180VB, 0170VB, 0180VA 0722RT, 0732RT, 0742RT, 0752RT, 1722RD, 1732RD, 1772RD 1782RD, 1792RD, 1802RD, 1802RDA, 1812RD, 1822RD, 0092RD, 0102RD, 0112RD, 0122RD, 0132RD, 0142RD, 0162RD 0172RD, 0182RD, 0192RD, 0212RD, 0202RD, 0062RD, 1451RD 1461RD, 1461RDA, 1511RD, 1521RD, 1531RD, 1661RD, 1481RD, 1571RD, 1581RD, 1591RD, 1601RD, 1611RD, 1621RD 1681RD, 1532RD, 1522RD, 1842RD, 1512RD, 1522RD, 1562RD 1582RD, 1572RD, 1722RD, 1732RD, 1742RD, 1772RD, 1782RD 1792RD, 1802RD, 1812RD, 1812RDA, 1822RD, 1842RD, 1852RD, 1872RD