US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 21, 2012 (14 years ago)

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

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

What was recalled

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

Recalling firm
American Enterprises LLC dba Sterling Gelatin
Origin
VA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-062-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.