Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A
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
- Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A
- 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-0089-2014
- Quantity
- one sample bottle, 100 gm
- 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 ALI13157-09; re-evaluation date 12/6/2014. **sample only - not tested On 10/22/2013 American Laboratories provided CFSAN a customer distribution list for the Chloramphenicol Contamination. This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet
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
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.