September 2012 FDA Recall Drug by American Enterprises Llc Dba Sterling Gelatin
D-062-2013 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by American Enterprises Llc Dba Sterling Gelatin on September 21, 2012 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-062-2013

Reason for Recall
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Initiated
09-21-2012
Reported
11-28-2012
Quantity
750 kgs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63550
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.
American Enterprises LLC dba Sterling Gelatin
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.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-28-2012
Product Description About Product Description
Full technical description of the product.
Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA

Batch or Lot Expiration Information

Batch# Batch No. SG4704, Exp 02/22/2017.