Limed Bone Gelatin — Class II drug recall D-062-2013
Terminated recall by American Enterprises LLC dba Sterling Gelatin, reported 2012-11-28, distributed in NJ. Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamina
| Recall number | D-062-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Enterprises LLC dba Sterling Gelatin, Prince George, VA, United States |
| Recall initiated | 2012-09-21 |
| Classified | 2012-11-21 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2012-11-28 |
| Distributed | NJ |
| Quantity | 750 kilograms |
| Reason classes | microbial contamination, sterility |
| Lot numbers | SG4704 |
| Model numbers | 164, P8095 |
| Expiration dates | 2017-02-22 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-062-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.