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Avion Pharmaceuticals, LLC: Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UP

FoodSource: FDA (food) · Date: 2025-12-10

⚠ Undeclared Soy

Read the official notice at FDA (food) →

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The text below is copied from the official FDA (food) record. If anything differs, the official notice is correct.

Company / brand
Avion Pharmaceuticals, LLC
Product
Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005
Reason / hazard
Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
Classification
Class III
Status
Ongoing
Distribution / sold at
Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.
Recall initiated
2025-10-29
Code info
Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
Product quantity
804 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Alpharetta
State
GA
Country
United States
Event id
97893
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