RecallHawk
Class I Recall

Multiple Vitamin B Capsules, 60 Capsules, Biologically Active Forms of Vitamin B12, Folate, B6. Packaged in bottles und

Euro-Pharma

Summary

The FDA issued a Class I for Multiple Vitamin B Capsules, 60 Capsules, Biologically Active Forms of Vitamin B by Euro-Pharma. Reason: undeclared allergen (milk).

Details

Source

Food Recall

External ID

F-0841-2023

Action Date

2023-05-17

Status

Terminated

Category

food

Product Description

Multiple Vitamin B Capsules, 60 Capsules, Biologically Active Forms of Vitamin B12, Folate, B6. Packaged in bottles under the following brands: 1. EuroMedica Active B Complex, Product #68006, UPC 3 67703 68006 0. Manufactured by a cGMP compliant facility exclusively for: Euromedica, 925 Challenger Drive, Green Bay, WI 54311. 2. Terry Naturally BioActive Vitamin B, Product #18006, UPC 3 67703-18006 5. Manufactured by a cGMP compliant facility exclusively for: EuroPharma, Inc., Green Bay, WI 54311.

Lot/Code Info: 1. Active B, Lot # 1220019, Best By Date: November 2022; Lot # 0921232, Best By Date: July 2023; Lot # 0222190, Best By Date: January 2024. 2. BioActiva, Lot # 1220022, Best By Date: October 2022; Lot # 0921231, Best By Date: July 2023; Lot # 0222192, Best By Date: January 2024; Lot # 0223570, Best By Date: December 2024.

Quantity Affected: 23,770 units total

Reason for Recall

undeclared allergen (milk)

Distribution

Nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2023-04-20

Company

Euro-Pharma

Green Bay, WI

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 111 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

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

How often does Euro-Pharma have FDA actions?

This is the only FDA action we have on record for Euro-Pharma in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0841-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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