Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and dis
Summary
The FDA issued a Class II for Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsu by New Dawn Nutrition, Inc.. Reason: Product contained undeclared milk, wheat, and soy..
Details
Source
Food Recall
External ID
F-0886-2021
Action Date
2021-09-01
Status
Terminated
Category
food
Product Description
Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and distributed by New Dawn Nutrition Omaha, NE
Lot/Code Info: Lot #361551 Best By 2022
Quantity Affected: 4 bottles
Reason for Recall
Product contained undeclared milk, wheat, and soy.
Distribution
Distributed to two retail consumers in the Omaha area.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-16
Company
Omaha, NE
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 40 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 (New Dawn Nutrition, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New Dawn Nutrition, Inc. have FDA actions?
This is the only FDA action we have on record for New Dawn Nutrition, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0886-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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