Colostrum Powder, Dietary Supplement, Allergen statement: contains dairy. C...
FDA Recall #F-1013-2016 — Class III — November 10, 2015
Recall Summary
| Recall Number | F-1013-2016 |
| Date Initiated | November 10, 2015 |
| Classification | Class III |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Immuno - Dynamics, Inc |
| Location | Fennimore, WI |
Product Description
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.
Classification
Class III — A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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).
Product Quantity
250 gram jars - 2,532 units. 150 gram jars - 68 units. 8.8 ounce jars - 11,008 units
Product Codes / Lot Numbers
250 gram jar Lots: 627-30, 628-30, 628-31, 630-31, 632-30, 633-30, 633-31, 635-30, 635-35, 636-30, 637-30, 637-31, 638-30, 638-31, 639-30, 639-31, 639-32, 641-30, 642-30, 644-30, 644-31, 646-30. 150 gram Jar Lots: 642-100 8.8 ounce jar Lots: 627-30, 628-30, 628-31, 630-31, 632-30, 633-30, 633-31, 635-30, 635-35, 636-30, 637-30, 637-31, 638-30, 638-31, 639-30, 639-31, 639-32, 641-30, 642-30, 644-30, 644-31, 646-30
What Should You Do?
Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.
Frequently Asked Questions
Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.
In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.
Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.
The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.