FDA recall F-1013-2016

Immuno - Dynamics, Inc · Class III · food

Product

Colostrum Powder, Dietary Supplement, Allergen statement: contains dairy. Colostrum (bovine) packaged in the following sizes and brand names: 1. PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099. 3,000 mg Colostrum (bovine) per 2 teaspoons. Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI 53809; 2. PerCoBa Extra Edge Net Weight 250 grams, UPC 90576-00001. 3,000 mg Colostrum (bovine) per 2 teaspoons. Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI 53809.; 3. Synertek Balanced Pure, 8.8 ounces, UPC 09408-29292. 1,500 mg Colostrum (bovine) per 1 teaspoon. Distributed by Synertek Colostrum, Inc., Cheyenne, WY 82009.

Reason for recall

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

Distribution

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).

Key facts

Status
Terminated
Initiation date
2015-11-10
Report date
2016-04-13
Termination date
2016-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fennimore, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1013-2016