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Class III: unlikely to cause harmTerminated

Immuno - Dynamics Colostrum Lozenges Recall

Colostrum Lozenges, Dietary Supplement, Colostrum (Bovine) 200mg

Immuno - Dynamics, Inc · Fennimore, WI

Risk level
Class III
Reported by FDA
Apr 13, 2016
Recall ID
F-1015-2016
Check your lot numberHow we source this data

Summary

Immuno - Dynamics recalled Colostrum Lozenges starting Nov 10, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-1015-2016 on Apr 13, 2016. Reason: The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk. Status: Terminated.

Why it was recalled

The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.

Product description

Colostrum Lozenges, Dietary Supplement, Colostrum (Bovine) 200mg. Allergen statement: contains dairy. Packaged in the following sizes and Brand names: 1. PerCoBa, UPC 90576-00006. 100 Lozenges Distributed by: Immuno-Dynamics, Inc., Fennimore, WI 53809; 2. Synertek, UPC 90576-00007. 100 lozenges. Distributed by: Synertek Colostrum, Inc., Cheyenne, WY 82009.

Lot numbers, UPCs & expiration codes

PerCoBa Lots: 627-20, 638-20. Synertek Lots: 627-20, 638-20.

Where it was sold

Nationwide to include Puerto Rico. Outside the US to include: Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1015-2016
Classification
Class III
Status
Terminated
Recall initiated
Nov 10, 2015
FDA report date
Apr 13, 2016
Quantity
PerCoBa 3,310 units. Synertek 9,468 units.
Recall type
Voluntary: Firm initiated
Recalling firm
Immuno - Dynamics, Inc

Original FDA data

Every field from FDA enforcement report F-1015-2016, exactly as published.

Show all FDA fields
City
Fennimore
State
WI
Status
Terminated
Country
United States
Event ID
72665
Address
1800 Dodge St
Code information
PerCoBa Lots: 627-20, 638-20. Synertek Lots: 627-20, 638-20.
Postal code
53809-2301
Report date
Apr 13, 2016
Product type
Food
Recall number
F-1015-2016
Classification
Class III
Recalling firm
Immuno - Dynamics, Inc
Product quantity
PerCoBa 3,310 units. Synertek 9,468 units.
Termination date
May 10, 2016
Reason for recall
The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Colostrum Lozenges, Dietary Supplement, Colostrum (Bovine) 200mg. Allergen statement: contains dairy. Packaged in the following sizes and Brand names: 1. PerCoBa, UPC 90576-00006. 100 Lozenges Distributed by: Immuno-Dynamics, Inc., Fennimore, WI 53809; 2. Synertek, UPC 90576-00007. 100 lozenges. Distributed by: Synertek Colostrum, Inc., Cheyenne, WY 82009.
Distribution pattern
Nationwide to include Puerto Rico. Outside the US to include: Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).
Recall initiation date
Nov 10, 2015
Initial firm notification
Letter
Center classification date
Apr 4, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1015-2016, published Apr 13, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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