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Euro-Pharma Recall: undeclared allergen (milk)

United States

TerminatedClass I

Company
Euro-Pharma
Product
Multiple Vitamin B Capsules, 60 Capsules, Biologically Activ…
Recall date
April 20, 2023
Terminated
September 19, 2023
Source
FDA

Reason for recall

undeclared allergen (milk)

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
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. Not published in this source record 23,770 units total 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.

Distribution

  • Nationwide

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-0841-2023
Event ID
92162
Status
Terminated
Classification
Class I
Company
Euro-Pharma
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.
Quantity
23,770 units total
Reason
undeclared allergen (milk)
Recall initiation date
April 20, 2023
Report date
May 17, 2023
Classification date
Not published in this source record
Termination date
September 19, 2023
Distribution pattern
Nationwide
UPC, lot, and code information
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.
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
E-Mail
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Euro-Pharma

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class I mean?

A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

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