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Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN ...

FDA Recall #D-062-2013 — Class II — September 21, 2012

Recall #D-062-2013 Date: September 21, 2012 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

American Enterprises LLC dba Sterling Gelatin — Prince George, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

750 kgs

Distribution

NJ

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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