FDA recall D-062-2013

American Enterprises LLC dba Sterling Gelatin · Class II · drug

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

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.

Distribution

Key facts

Status: Terminated
Initiation date: 2012-09-21
Report date: 2012-11-28
Termination date: 2012-11-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Prince George, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-062-2013