May 2013 FDA Recall Drug by Faria Limited Llc Dba Sheffield Pharmaceuticals
D-604-2013 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Faria Limited Llc Dba Sheffield Pharmaceuticals on May 28, 2013 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed in PA, GA, WA, CA and the recall is currently terminated.

Recall Number: D-604-2013

Reason for Recall
Failed Stability Specifications: Unable to meet shelf life expiry.
Initiated
05-28-2013
Reported
06-26-2013
Quantity
105,744 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65349
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.
Faria Limited LLC dba Sheffield Pharmaceuticals
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.
PA, GA, WA, CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2014
Product Description About Product Description
Full technical description of the product.
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)

Batch or Lot Expiration Information

Lot# 10301, Exp 05/14
Lot# 10302, Exp 05/14