# FDA recall D-062-2013

> **American Enterprises LLC dba Sterling Gelatin** · Class II · drug recall initiated 2012-09-21.

## 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

NJ

## Key facts

- **Recall number:** D-062-2013
- **Recalling firm:** American Enterprises LLC dba Sterling Gelatin
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-062-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-062-2013. Source: US FDA. Licensed CC0.

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