NOW Health Group Issues Voluntary Recall on Phosphatidyl Serine Not Meeting Label Claim
Bloomingdale, IL (January 10, 2024) - NOW Health Group is conducting a voluntary recall of NOW® Phosphatidyl Serine Extra Strength 300 mg Softgels 50 count, Product Code 2392, Lots #3316650 and #3309243 and Protocol For Life Balance® Product Code P2392, Lots #3309194 and #3316624. Testing has shown that some units of these lot numbers do not meet label claim. There was an issue with the homogeneity of the material throughout the lots causing some units to test below the stated label claim while others tested to specification.
NOW was first alerted to the low potency issue by a ConsumerLab.com report on January 5, 2024 and, surprised at the results given NOW’s industry-leading quality protocols, immediately began an investigation. NOW’s specification is to add 8% overage for this product, meaning 324 mg Phosphatidyl Serine is input into this product normally, using a trademarked ingredient. Because NOW’s in-house softgels manufacturing capacity at the Sparks, Nevada facility doesn’t fill all the demand, the company uses contract manufacturers for some softgel products, including this one. The pre-shipment samples of this lot NOW tested in its third-party ISO-accredited analytical and micro lab passed at over 300 mg/softgels. However, the investigation this week determined that the lot is inconsistent, indicating that the contract manufacturer is having difficulty blending lecithin and achieving uniformity.
“While there is no health risk in this situation, we take regulatory compliance and meeting label claims seriously, and giving consumers what they pay for even more seriously,” said Dan Richard, NOW Health Group VP of Global Sales and Marketing. “We appreciate being alerted to this issue by ConsumerLab.com, which is a catalyst to reexamine our already robust quality assurance oversight. We are issuing a voluntary recall and being transparent with the industry as a first step, to be followed by adding additional safeguards to our QA protocols, especially for products we don’t make ourselves.”
NOW is working with the FDA to execute the voluntary recall, which includes contacting all customers that ordered the affected products with detailed instructions on next steps.
ABOUT NOW®:
Founded by Elwood Richard in 1968 on the belief that natural is better, NOW has grown from a small family operation into one of the most highly respected manufacturers in the natural products industry. Still a family-owned company today, NOW provides customers with a comprehensive approach to wellness by offering more than 1,400 dietary supplements, functional foods, sports nutrition, health and beauty products, and essential oils. NOW is committed to offering safe, affordable products of the highest quality and is a highly regarded advocate in the natural products industry. After more than 55 years in the natural products industry, NOW remains committed to its original mission – to provide value in products and services that empower people to lead healthier lives.
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