Food recall

American Laboratories Inc recall: Pectinase 3

American Laboratories Inc, of Omaha, NE, recalled Pectinase 3 and 8 other products. The FDA's reason: “The products may be contaminated with Chloramphenicol.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on September 30, 2013, and the FDA first listed it in its Enforcement Report of November 13, 2013. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

See FDA's words below

Status

Terminated

Closed April 16, 2014

The recall

Company
American Laboratories Inc (Omaha, NE)
Reason, in FDA's words
“The products may be contaminated with Chloramphenicol.”
Where it was sold
Distribution was made to IA, UT, NV, NE and CA.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
66445

The 9 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0089-2014 Class II

    Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A

    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

    Quantity: one sample bottle, 100 gm

  • F-0090-2014 Class II

    Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A

    Codes: Lot ALI13157-11; re-evaluation date 12/6/2014 **sample only - not tested

    Quantity: 1 sample bottle, 100 gm

  • F-0091-2014 Class II

    Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A

    Codes: Lot ALI13206-05; re-evaluation date 1/25/2015 **sample only - not tested

    Quantity: 1 sample bottle, 100 gm

  • F-0092-2014 Class II

    Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A

    Codes: Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014 **sample only - not tested

    Quantity: 2 sample bottles, 100 gm bottles

  • F-0093-2014 Class II

    NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A

    Codes: 15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104. **Lot ALI13212-04 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product"

    Quantity: 1/23 KG-box and 2/15 KG-box

  • F-0094-2014 Class II

    PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A

    Codes: 9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014. **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product"

    Quantity: 2/25 KG-boxes and 9.4 KG box

  • F-0095-2014 Class II

    Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678.

    Codes: Lot # ALI13053-05; re-evaluation date 8/22/2104 **Lot ALI13053-05 mathmatical analysis tested "VERY probable NOT < 0.3 ppb in final product"

    Quantity: 1/25 KG-box

  • F-0096-2014 Class II

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

    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"

    Quantity: 4/5 KG-boxes

  • F-0097-2014 Class II

    EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C

    Codes: Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014. **Lot ALI13200-08 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"

    Quantity: 4/5 KG-boxes

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of November 13, 2013.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.