Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following brands and sizes. 1. Ortho Mol
Summary
The FDA issued a Class II for Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the fo by Ortho Molecular Products, Inc.. Reason: Raw material tested positive for Cronobacter sakazakii..
Details
Source
Food Recall
External ID
F-0340-2023
Action Date
2023-02-15
Status
Terminated
Category
food
Product Description
Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following brands and sizes. 1. Ortho Molecular Products Fiber Plus, Product #608445, Net Wt. 15.9 oz (450 Grams) UPC 6 15033-00608 2. Ortho Molecular Products, Inc., 3017 Business Park Drive, Stevens Point, WI 54482. 2. Utzy Naturals, Daily Fiber Drink Mix. Net Wt 5.95 oz (168.75 Grams), UPC 8 56420-00632 6. Manufactured for Utzy Naturals, 623 West Main St., Lake Geneva, WI 53147. 3. Ortho Molecular Products Fiber Plus, Product #608445CAN, 450 g, UPC 6 15033-04608 8. Ortho Molecular Products, Inc. 54482 United States. Product is sold in Canada. 4. Ortho Molecular Products Fiber Plus, Product #608445C, Net Wt. 15.9 oz (450 Grams) UPC 6 15033-01608 1. . Ortho Molecular Products, Inc., 3017 Business Park Drive, Stevens Point, WI 54482. Contains CA Prop 65. 5. Unbranded bottled product in 1000cc bottle to be given out by healthcare provider. 608.008J UPC 6 15033 60608 4. 6. Unbranded bottled product in 1000cc bottle to be given out by healthcare provider. 608C.009H UPC 6 15033 61608 3. Contains CA Prop 65.
Lot/Code Info: Lot 87121 Product Number 608445, 608445C, 608445CAN, and 608445U UPC 615033006082, 615033016081, 615033046088, and 615033606084 Expiration Date 06/30/23 Lot 87059 Product Number 608445, 608445C, 608445CAN, UTZ100-1300168, 608445U UPC 615033006082, 615033016081, 615033046088, 615033606084, and 856420006326 Expiration Date 06/30/23
Quantity Affected: 4,929 bottles
Reason for Recall
Raw material tested positive for Cronobacter sakazakii.
Distribution
Nationwide. Outside the US to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-12
Company
Stevens Point, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 30 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho Molecular Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho Molecular Products, Inc. have FDA actions?
This is the only FDA action we have on record for Ortho Molecular Products, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0340-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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