June 2012 FDA Recall Drug by Fougera Pharmaceuticals, Inc.
D-1426-2012 - Chemical Contamination

This Class III drug recall was voluntarily initiated by Fougera Pharmaceuticals, Inc. on June 7, 2012 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1426-2012

Reason for Recall
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Initiated
06-07-2012
Reported
08-01-2012
Quantity
444 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62136
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.
Fougera 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.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2015
Product Description About Product Description
Full technical description of the product.
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.

Batch or Lot Expiration Information

Lot# : 418N, Exp 06/13