URGENT: DIETARY SUPPLEMENT RECALL

Transcription

1 URGENT: DIETARY SUPPLEMENT RECALL May 26, 2011 Re: NOW Calcium & Magnesium Softgels Product Codes 1251, 1252 Dear Valued Customer: NOW Foods is conducting a voluntary recall of selected lots of all sizes of NOW Calcium & Magnesium Softgels (Product Code 1251, 1252). We are recalling the above referenced products because it has been determined that these products contain excessive amounts of Vitamin D3, which may represent a health hazard for some people. See attached FAQs for further details. The product lots listed on the attached Recall Form were all manufactured containing a high amount of Vitamin D3. This problem was discovered during the routine investigation of a product complaint. We are aware of the trust you place in us each day as you sell our products. We take this matter very seriously, and we will do everything we can to retain your confidence and trust. Please accept our sincere apology. Other NOW Foods products containing Vitamin D3 and other NOW Foods Calcium & Magnesium products are not affected and are not involved in this recall. We ask that you immediately take the following steps: 1. Examine your stocks to determine if you have any of the lots listed on the attached Recall Form. 2. If you have any of the lots listed on the attached Recall Form please discontinue selling it and remove it from store shelves immediately. (Continued on next page)

2 3. Inform your customers to stop taking these products and return them to your store. Please make every effort to contact your customers. No receipt should be required for returns. Suggested methods of contact include identification of customer usage via customer loyalty programs, and s to customers. We will also provide in store signage as part of this recall. We appreciate your cooperation in this important matter of encouraging your customers to return any affected product. 4. Note your name and customer number on the Recall Form. A. If you have these items in inventory, enter the quantity you have for each item by lot on the Recall Form provided. Box this product in preparation for return to NOW Foods. Do not place the Recall Form in the box and do not dispose of product yourself. It is essential that you return all products to NOW Foods. B. If you do not have any of the listed lots left in your inventory, please enter 0 for each lot on your Recall Form. Return the form via fax or mail immediately. It is very important that you return the completed form to us with a quantity entered for each lot even if you do not have any remaining inventory. C. For consumer returns, please notify customer service for additional instructions. 5. Call Customer Service: 888 NOWFOODS ( ) to obtain a Return Materials Authorization (RMA) number. Customer Service will be available during regular business hours, Mon. Fri., 8 a.m. to 6 p.m. CST. Please do not return any product until you have obtained an RMA number and call tag. 6. Write your RMA number on your Recall Form. (Continued on next page)

3 7. Please fax your completed form to or mail to: NOW Foods Customer Service Dept. 395 S. Glen Ellyn Rd. Bloomingdale, IL We will provide reimbursement for the returned product by providing a credit memo to your account for the amount of product returned. We will notify you when new production of Calcium & Magnesium (1251, 1252) is available to order. If you have any questions, please contact our Customer Service Department at 888 NOWFOODS ( ). Please note that the FDA may survey a small number of our customers to confirm that our recall logistics were effective. This survey may be by phone, mail or, in person. Again, please accept our sincere apology. Thank you very much for your prompt attention to this matter.

4 RECALL FORM Customer Name Customer # RMA# Please obtain RMA# by calling NOW Foods at Item Number Description Lot Number 1251 Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 120 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels Cal/Mag 240 Softgels # of Bottles Returned from Stock # of Bottles Returned by Your Customers FOR NOW FOODS USE ONLY # Received QC Logged By/Date

5 Cal/Mag with Vitamin D (NOW Product Codes 1251, 1252) Recall FAQs May 26, 2011 These products are being recalled because of high levels of vitamin D. How high are the Vitamin D levels in the product? The label amount of vitamin D is 600 IU per recommended daily serving size of 3 softgels. The products were manufactured with vitamin D levels of about 30,000 40,000 IU per 3 softgels. For comparison, the RDA (Recommended Daily Allowance) is 1,000 IU. Doses of vitamin D as high as 50,000 IU are routinely prescribed for once weekly treatments of vitamin D deficiency. What are the side effects of high Vitamin D exposure? In most cases you may not experience any side effects. Symptoms of high vitamin D dietary intake include weakness, fatigue, sleepiness, headache, loss of appetite, dry mouth, metallic taste, nausea, vomiting, abdominal cramps, constipation, diarrhea, dizziness, ringing in the ears, trouble walking, skin eruptions, muscle pain, bone pain, and irritability. Advanced symptoms may include runny nose, itching, increased frequency of urination, nighttime awakening to urinate, and thirst may occur. It can take some time for vitamin D to reach levels associated with side effects. Note that these symptoms may also be associated with unrelated conditions and may not be indicative of high vitamin D levels. In addition to increased blood vitamin D levels, laboratory tests may show serious health consequences, such as hypercalcemia (high levels of calcium), azotemia (high levels of nitrogen containing compounds like urea and creatine), and anemia (decreased blood cells). Prolonged hypercalcemia results in calcium deposits in soft tissues, which may result in hypertension and may also result in heart rhythm abnormalities. Again, these conditions may occur unrelated to high vitamin D levels. What is the expected duration of symptoms? It is expected that most effects are temporary and reversible over time. (Continued on next page)

6 Cal/Mag with Vitamin D (NOW Product Codes 1251, 1252) Recall FAQs (continued) What should I do if I m taking this product? Please immediately discontinue use of this product. If you have been taking the recalled product for an extended period of time and are concerned, please consult a doctor or other healthcare practitioner. NOW has a variety of other Calcium & Magnesium products for your use, such as 1265, 1266, and No other NOW products are affected by this Recall. Why did this recall occur? As with most softgel products, these products are made by a specialized softgel manufacturer. The elevated levels of Vitamin D were discovered during the routine investigation of a product complaint. Upon further investigation an error was found in the softgel manufacturing formula, which resulted in excess levels of Vitamin D3 in the product. What is NOW Foods doing about this? We are revising our quality procedures and manufacturing checks on all softgel products. These improved procedures are designed to prevent this type of manufacturing error from occurring in the future. When can I expect to get replacement product? We have already started the production process using our revised quality procedures. You should be able to place an order for these newly produced Calcium & Magnesium products (1251 and 1252) within a few weeks. What if I have other questions? Please contact Customer Service and we will get back to you promptly with an answer. Customer Service contact information phone: 888 NOWFOODS ( ), customerservice@nowfoods.com.