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Terminated

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.

FDA Recall Z-0787-06 · Posted 2006-04-20

Recall StatusTerminated
Product CodeJTR
Date Initiated2006-03-29
Date Terminated2012-03-01
Product Quantity10 vials of 100 dose and 3 vials of 20 dose.

Reason for Recall

Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed.

Firm Action

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.

Root Cause

Other

Distribution Pattern

The recalled product was distributed to direct account/customers located in CA, CO, GA, IL, NE, OH , PR and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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