EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box.

American Laboratories Inc recalled this product and the FDA reported the enforcement action on 13 November 2013 as Class II. The recall was initiated by the firm. The products may be contaminated with Chloramphenicol.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C

Reason for recall

The products may be contaminated with Chloramphenicol.

Recalling firm

American Laboratories Inc

Firm location

Omaha, Nebraska, United States

Classification

Class II

Status

Terminated

Recall number

F-0096-2014

Quantity

4/5 KG-boxes

Distribution

Distribution was made to IA, UT, NV, NE and CA.

Initiated

30 September 2013

Reported by FDA

13 November 2013

Terminated

16 April 2014

Firm notified by

Telephone

Product codes

Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014. **Lot ALI13200-09 mathmatical analysis tested "probably < 0.3 ppb in final product" **the other three lots mathmatical analysis tested "probably NOT < 0.3 ppb in final product"

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This is one of 9 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 9 separate recalls, which almost every published figure does, overstates it by a factor of 9. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 9 of them.
• The recall ran for 7 months, from 30 September 2013 to termination on 16 April 2014. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The distribution pattern names 4 states, and the FDA published the enforcement report 6 weeks after the firm began the recall.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Named in the distribution pattern: Utah, Nevada, Nebraska, California. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from American Laboratories Inc

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 8 other records name this firm.

All 9 records for American Laboratories Inc

All 2013 recalls · All FDA food recall data