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Class II

American Laboratories Inc

Recall #F-0089-2014 · Initiated 2013-09-30

Product
Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A
Reason for recall
The products may be contaminated with Chloramphenicol.
Quantity affected
one sample bottle, 100 gm
Distribution
Distribution was made to IA, UT, NV, NE and CA.
Lot / code info
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
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Telephone
Terminated
2014-04-16

Recalling firm

American Laboratories Inc
4410 S 102nd St
Omaha, NE 68127-1003
United States

Recall classification

Remote probability of serious adverse health consequences, or temporary reversible consequences.

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