Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: ''b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well''. The product is distributed by and/or manufactured by BEC Laboratories, Inc., 705 Front Street, Toledo, OH 43605.
- Recall Initiated
- March 29, 2006
- Posted
- April 20, 2006
- Terminated
- March 1, 2012
- Recall Number
- Z-0787-06
- Quantity
- 10 vials of 100 dose and 3 vials of 20 dose.
- Firm Location
- Toledo, OH
Reason for Recall
Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed.
Distribution
The recalled product was distributed to direct account/customers located in CA, CO, GA, IL, NE, OH , PR and TX.
Lot / Code Info
AN1 (100 dose) Lot #022206 - 16404-100, Exp. Date: August 22, 2006, and AN5 (20 dose) Lot #022206 - 16404-20, Exp. Date: August 22, 2006.
Root Cause
Other
Action Taken
BEC Laboratories, Inc. sent an ''URGENT PRODUCT RECALL NOTICE'' to their direct account customers via fax transmission on 3/29/2006. The letter informs the customers of the adulteration of the product with yeast and notifies the customers that new suspensions of aspergillus niger will be arriving shortly. The recall letter asks that the customers 1) Destroy the defective lots of product immediately after receiving their shipment of replacement product and that they; 2) Notify their subaccounts of the firm''s recall and ask the subaccount customers to destroy any of the recalled product in their possession. In addition, the recall notice also asks that the direct account customers complete an enclosed ''Product Recall Veriftcation form'', and return it to the recalling firm. This form asks the customers: 1) How many vials from each suspect lot of product have been received? 2)How many vials have been destroyed? 3) in what manner were they destroyed; 4) How many vials have been further distributed to subaccounts; and 5) The name & location of the subaccounts. The Product Recall Verification Form also asks: whether or not the replacement vials of product have been received; and the date on which they were received, and it asks for a signature from the individual who completed the form.