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Class II: temporary or reversible health riskTerminated

Ortho Molecular Products Fiber Powder Recall

Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following…

Ortho Molecular Products, Inc. · Stevens Point, WI

Risk level
Class II
Reported by FDA
Feb 15, 2023
Recall ID
F-0340-2023
Check your lot numberHow we source this data

Summary

Ortho Molecular Products recalled Fiber Powder starting Jan 12, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0340-2023 on Feb 15, 2023. Reason: Raw material tested positive for Cronobacter sakazakii. Status: Terminated.

Why it was recalled

Raw material tested positive for Cronobacter sakazakii.

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 numbers, UPCs & expiration codes

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

Where it was sold

Nationwide. Outside the US to Canada.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0340-2023
Classification
Class II
Status
Terminated
Recall initiated
Jan 12, 2023
FDA report date
Feb 15, 2023
Quantity
4,929 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Ortho Molecular Products, Inc.

Original FDA data

Every field from FDA enforcement report F-0340-2023, exactly as published.

Show all FDA fields
City
Stevens Point
State
WI
Status
Terminated
Country
United States
Event ID
91515
Address
3017 Business Park Dr
Code information
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
Postal code
54482-8835
Report date
Feb 15, 2023
Product type
Food
Recall number
F-0340-2023
Classification
Class II
Recalling firm
Ortho Molecular Products, Inc.
Product quantity
4,929 bottles
Termination date
Apr 9, 2024
Reason for recall
Raw material tested positive for Cronobacter sakazakii.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide. Outside the US to Canada.
Recall initiation date
Jan 12, 2023
Initial firm notification
Telephone
Center classification date
Feb 3, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0340-2023, published Feb 15, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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