RecallHawk
Class II Recall

NATURE's ANSWER Coral Calcium; Antioxidant Benefits*; 1000mg Coral Calcium per serving; DIETARY SUPPLEMENT; 90 capsules

Bio-Botanica, Inc.

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

Bio-Botanica, Inc.

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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