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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 66445
Product Type Food
Status Ongoing
Recalling Firm American Laboratories Inc
City Omaha
State NE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-30
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Distribution was made to IA, UT, NV, NE and CA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C 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" Class II The products may be contaminated with Chloramphenicol. 4/5 KG-boxes F-0096-2014
Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678. Lot # ALI13053-05; re-evaluation date 8/22/2104 **Lot ALI13053-05 mathmatical analysis tested "VERY probable NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. 1/25 KG-box F-0095-2014
PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A 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" Class II The products may be contaminated with Chloramphenicol. 2/25 KG-boxes and 9.4 KG box F-0094-2014
NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A 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" Class II The products may be contaminated with Chloramphenicol. 1/23 KG-box and 2/15 KG-box F-0093-2014
Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. 2 sample bottles, 100 gm bottles F-0092-2014
Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A Lot ALI13206-05; re-evaluation date 1/25/2015 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. 1 sample bottle, 100 gm F-0091-2014
Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A Lot ALI13157-11; re-evaluation date 12/6/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. 1 sample bottle, 100 gm F-0090-2014
Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A 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 Class II The products may be contaminated with Chloramphenicol. one sample bottle, 100 gm F-0089-2014
EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C 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" Class II The products may be contaminated with Chloramphenicol. 4/5 KG-boxes F-0097-2014
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