NATURE's ANSWER Coral Calcium; Antioxidant Benefits*; 1000mg Coral Calcium per serving; DIETARY SUPPLEMENT; 90 capsules
Summary
The FDA issued a Class II for NATURE's ANSWER Coral Calcium; Antioxidant Benefits*; 1000mg Coral Calcium per s by Bio-Botanica, Inc.. Reason: Product contained cesium chloride, a New Dietary Ingredient.
Details
Source
Food Recall
External ID
F-1000-2022
Action Date
2022-04-20
Status
Terminated
Category
food
Product Description
NATURE's ANSWER Coral Calcium; Antioxidant Benefits*; 1000mg Coral Calcium per serving; DIETARY SUPPLEMENT; 90 capsules
Lot/Code Info: Lot 203279 - 9/2020; Lot 194079 - 12/2019; Lot 190719-4/2019; Lot 183383 - 9/2018
Quantity Affected: 6852 bottles
Reason for Recall
Product contained cesium chloride, a New Dietary Ingredient
Distribution
RI, FL, IN, OK, WI, TX, MI, CA, MO, PA, TN, NY, AZ, DE, VA, CT, OH
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-13
Company
Hauppauge, NY
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 (Bio-Botanica, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bio-Botanica, Inc. have FDA actions?
This is the only FDA action we have on record for Bio-Botanica, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1000-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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