RE: Reported clumps in KetoCal® LQ affecting tube feeding individuals Dear KetoCal Community, Nutricia North America recently received a limited number of reports regarding clumps in KetoCal Liquid/LQ resulting in clogging of feeding tubes. At Nutricia we take all reports and complaints seriously. KetoCal 4:1 Liquid/LQ is safe for consumption The ketogenic ratio (4:1) and nutritional composition are not affected by the clumping. We have thoroughly investigated all reports and conducted extensive quality assurance tests. Results from these tests indicate that both the nutrient content of KetoCal Liquid/LQ and the ketogenic ratio (4:1) meet label specifications. As such, the product is safe for consumption.
The high fat nature of KetoCal Liquid/LQ naturally results in a certain level of creaming during processing, storage and transportation. Thorough shaking is therefore essential to properly mix product and help reduce level of creaming. Variability in product creaming may lead to small, soft creamy clumps even after shaking. We have received reports that these small clumps may clog tube feeding equipment. Recommended use of KetoCal Liquid/LQ
We are committed to the highest standards of safety and quality to meet your needs. Nutricia North America will continue to work towards resolving the clumping in KetoCal Liquid/LQ. Please refer to the “KetoCal Liquid/LQ Clumping Q&A” to help clarify the situation further. We apologize for any inconvenience caused to you. For further details or to reach our Nutrition Services Department, please call toll-free 1-800-365-7354, Option 2, Monday through Friday 8:30 am – 7:00 pm EST; Afterhours press Option 9, or e-mail us at nutritionservices@nutricia.com. Sincerely, Dr. Steven Yannicelli, PhD, RD |
| KetoCal Liquid/LQ Clumping Q&A: |
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What is the clumping problem? Because this product is high in fat, there is a tendency for it to form a cream during processing, storage and transportation. The level of creaming varies and not all product is affected to the same degree. For most product, shaking will resolve the clumping but for some product, there may be small, soft creamy clumps remaining in the product after it is shaken. Is clumping occurring in all boxes? As mentioned above, all product may have a certain level of creaming but in most cases, shaking will resolve this. Certain product may have clumps even after shaking. Is this product safe for oral feedings? The product is safe to use when shaken before use as indicated on the product label. We recommend that the product is shaken vigorously for at least 5 seconds. The nutritional content and ketogenic ratio (4:1) do not change regardless of the clumping. Is this product safe for tube feedings? We advise caution in using the product for individuals dependent on feeding tubes due to the possibility of clogging the feeding tube. The nutritional content and ketogenic ratio (4:1) do not change regardless of the clumping. How should I reduce the clumps? SHAKE VIGOROUSLY FOR AT LEAST 5 SECONDS. What should I do if the clumps clog the feeding tube? Contact your medical professional. If the clumping persists, can I get replacement product? Yes. Please contact our Nutrition Services Department at our toll-free number: 1-800-365-7354, Monday through Friday 8:30 am – 7:00 pm EST, or e-mail us at nutritionservices@nutricia.com. Where can I get more information? Contact our Nutrition Services Department at our toll-free number: 1-800-365-7354, Monday through Friday 8:30 am – 7:00 pm EST, e-mail us at nutritionservices@nutricia.com, or visit our website at www.myKetoCal.com.
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May 2, 2011
Variability in creaming may lead to small clumps
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