Last month, we reported that, according to Nielsen-Massey Vanillas, Inc. of Waukegan, Illinois, it had recalled one lot of its Nielsen-Massey Madagascar Bourbon Pure Vanilla Bean Paste. The recall was issued over concerns that the vanilla bean paste was potentially contaminated with the foodborne pathogen, Listeria monocytogenes. Now, says Nielsen-Massey Vanillas, the recall of its Madagascar Bourbon Pure Vanilla Bean Paste has been found to be based on a false-positive <"https://www.yourlawyer.com/topics/overview/listeria">Listeria reading that had been reported by the company’s outside testing laboratory.
According a press release fom the company, follow-up investigations and additional testing conducted by the U.S. Food and Drug Administration (FDA), the outside lab in question, and another independent lab brought in to re-verify the results, were all returned with negative findings. Also, there were no positive results in any of the raw material used or for any of the equipment used in the process.
The other independent lab and the FDA laboratory, using the exact same gallon bottle of Paste, which tested positive initially, found no trace of Listeria whatsoever, said Nielsen-Massey Vanillas. Because the FDA did not have any findings for the Listeria pathogen as a result of its investigation, no Form 483 was issued.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in his/her judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The Form advises the firm of objectionable conditions and serves to encourage companies to respond in writing with its corrective action plan and to expeditiously implement that plan, according to the FDA. Again, in this case, a Form 483 was not issued.
On May 16, 2011, Nielsen-Massey’s outside testing laboratory advised Nielsen-Massey that it had detected potential Listeria monocytogenes contamination in lot no. 11123 of its Madagascar Bourbon Pure Vanilla Bean Paste product. The testing was part of its regular quality control testing. Nielsen-Massey notified the agency and wrote and sent a dispatch letter to its customers within 24 hours of the lab’s notification.
There have been no reports of illness related to Nielsen-Massey’s products and the recall did not affect Nielsen-Massey’s other products.
“We acted immediately when consumer safety became an issue,†said Craig Nielsen, chief executive officer. “And we would do the same thing again, since an error on the side of safety is almost always the right thing to do. But, it’s extremely unfortunate that a laboratory error caused such inconvenience to our customers and consumers. We’ve notified all our customers and have apologized to them as well.â€
The product that was subject to recall because of the test error was packaged in translucent plastic one-gallon and one-quart containers under the name Nielsen-Massey Madagascar Bourbon Pure Vanilla Bean Paste, lot no. 11123, through a variety of distribution channels, including direct delivery to business customers, distributors, and retail sales.
Customers with questions may contact Nielsen-Massey at 800.525.PURE (7873) or 847.578.1550, Monday through Friday, 9:00 a.m. until 4:00 p.m. Central Daylight Time (CDT).
