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Class II: temporary or reversible health riskTerminated

American Enterprises LLC dba Sterling Gelatin Limed Bone Gelatin Recall

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

American Enterprises LLC dba Sterling Gelatin · Prince George, VA

Risk level
Class II
Reported by FDA
Nov 28, 2012
Recall ID
D-062-2013
Check your lot numberHow we source this data

Summary

American Enterprises LLC dba Sterling Gelatin recalled Limed Bone Gelatin starting Sep 21, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-062-2013 on Nov 28, 2012. Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Status: Terminated.

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.

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

NJ

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-062-2013
Classification
Class II
Status
Terminated
Recall initiated
Sep 21, 2012
FDA report date
Nov 28, 2012
Quantity
750 kgs
Recall type
Voluntary: Firm initiated
Recalling firm
American Enterprises LLC dba Sterling Gelatin

Original FDA data

Every field from FDA enforcement report D-062-2013, exactly as published.

Show all FDA fields
City
Prince George
State
VA
Status
Terminated
Country
United States
Event ID
63550
Address
4595 Sandesara Dr
Code information
Batch No. SG4704, Exp 02/22/2017.
Postal code
23875-3045
Report date
Nov 28, 2012
Product type
Drugs
Recall number
D-062-2013
Classification
Class II
Recalling firm
American Enterprises LLC dba Sterling Gelatin
Product quantity
750 kgs
Termination date
Nov 28, 2012
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
NJ
Recall initiation date
Sep 21, 2012
Initial firm notification
Letter
Center classification date
Nov 21, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-062-2013, published Nov 28, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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