Sterling Gelatin Recalls Limed Bone Gelatin Due to C. Difficile Contamination
American Enterprises LLC is recalling 750 kgs of Limed Bone Gelatin due to possible C. difficile contamination in the raw material.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (C. difficile) without reported illness, which aligns with the rubric criteria for a High severity score.
Plain-English summary
American Enterprises LLC dba Sterling Gelatin is recalling 750 kgs of Limed Bone Gelatin. The product is packaged in six 125 kg fiber drums and labeled with PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA. The specific batch number is SG4704, with an expiration date of 02/22/2017.
The recall is being conducted due to possible microbial contamination by C. difficile discovered in the raw material. The product is classified as a non-sterile product. The distribution pattern for this recall is limited to New Jersey (NJ).
Consumers and businesses in New Jersey who possess this specific lot of Limed Bone Gelatin should stop using it and contact the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- American Enterprises LLC dba Sterling Gelatin
- Category
- Food — Gelatin
- Affected units
- 750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch No. SG4704
- Exp 02/22/2017.
Distribution
Distributed in 1 state:
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