Thursday, August 4, 2011

Calcium/Magnesium with Vitamin D Recall Update

An update from Michael Leiah, Ph.D., Technical Director of NOW Foods

We recently recalled several lots of Calcium/Magnesium with Vitamin D Softgels (items 1251 & 1252) because of high levels of Vitamin D. The problem came to our attention when we received two adverse event reports from consumers who underwent a regular blood screening and were found to have high levels of Vitamin D. We immediately started investigating. Like most manufacturers, we outsource our softgels, because softgel manufacturing is a very specialized process. Our specifications to our manufacturer were checked and were correct. However, we found that the manufacturer made a mistake in the batch calculation. The day we confirmed the mistake we issued the recall. Corrective actions are now in place to prevent the possibility of a similar error. As of mid-June, a new batch of Cal/Mag with Vitamin D Softgels was released and is now available. It is easy to identify this batch as the phrase "Easily Absorbed" was added  to the upper left hand corner of the label. This new batch has been double and triple-checked to assure formulation accuracy.

The question some of you are asking is how did the error occur in the first place? The answer is that it is extremely difficult to accurately test for low concentrations of Vitamin D in the finished product using High Performance Liquid Chromatography (HPLC) because of "matrix interference" from the other ingredients. We were testing these products for the two primary ingredients, calcium and magnesium, but due to the matrix interference issues we weren't able to test for the secondary ingredient Vitamin D. Vitamin D in the product can only be tested by coupling HPLC with research-grade detection equipment generally not available in most commercial labs. WE have located and are working with a contract laboratory with the sophisticated analytical instrumentation necessary to test for Vitamin D in low levels, and are using this instrumentation to ensure that what is on our label is in the product. We've also implemented additional in-house quality assurance for this product, but also for other products we outsource for manufacturing.


We are working very hard to retain your trust in our brand. I welcome suggestions and comments that can help make us even better.

In Good Health,

Michael Leiah, Technical Director
NOW Foods


**An update from THE HEALTHY WAY - **

We now have new inventory of the NOW Cal/Mag with Vitamin D. Two sizes available!
120 count = 12.99 S.R.P.  &  240 count = $23.99 S.R.P.
And remember...we still give a 15% discount on all NOW supplements!

1 comment: