RecallHawk
Class III Recall

ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.

ActiPharma, Inc.

Summary

The FDA issued a Class III for ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot by ActiPharma, Inc.. Reason: FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the lab.

Details

Source

Food Recall

External ID

F-0463-2024

Action Date

2023-11-29

Status

Terminated

Category

food

Product Description

ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.

Lot/Code Info: Lot 13309, Exp: 01/26

Quantity Affected: 607 bottles of 100 tablets each

Reason for Recall

FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.

Distribution

Domestic distribution, in Puerto Rico.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-09-28

Company

ActiPharma, Inc.

Guaynabo, PR

Context & Analysis

This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.

This was one of 55 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class III recall?

A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.

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 (ActiPharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does ActiPharma, Inc. have FDA actions?

This is the only FDA action we have on record for ActiPharma, Inc. in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0463-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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