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Class III: unlikely to cause harmTerminated

HP Ingredients NIKKENWELLNESS KENZEN brand Calcium Complex Recall

NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets

HP Ingredients · Bradenton, FL

Risk level
Class III
Reported by FDA
Oct 30, 2019
Recall ID
F-0069-2020
Check your lot numberHow we source this data

Summary

HP Ingredients recalled NIKKENWELLNESS KENZEN brand Calcium Complex starting Sep 26, 2019. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-0069-2020 on Oct 30, 2019. Reason: Calcium Complex label does not bear a "Contains: milk" advisory in the correct format. Status: Terminated.

Why it was recalled

Calcium Complex label does not bear a "Contains: milk" advisory in the correct format.

Product description

NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads "Contains ingredients derived from dairy" under Recommended Use.

Lot numbers, UPCs & expiration codes

10135903, 9417805, 9407804, 9335803, 9203802, 8813708

Where it was sold

Product was manufactured and distributed to Multi level Marketing firm, NIKKEN WELLNESS

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-0069-2020
Classification
Class III
Status
Terminated
Recall initiated
Sep 26, 2019
FDA report date
Oct 30, 2019
Quantity
4,400 bottles (60 tablets each)
Recall type
Voluntary: Firm initiated
Recalling firm
HP Ingredients

Original FDA data

Every field from FDA enforcement report F-0069-2020, exactly as published.

Show all FDA fields
City
Bradenton
State
FL
Status
Terminated
Country
United States
Event ID
83911
Address
707 24th Ave W
Code information
10135903, 9417805, 9407804, 9335803, 9203802, 8813708
Postal code
34205-8272
Report date
Oct 30, 2019
Product type
Food
Recall number
F-0069-2020
Classification
Class III
Recalling firm
HP Ingredients
Product quantity
4,400 bottles (60 tablets each)
Termination date
Feb 19, 2020
Reason for recall
Calcium Complex label does not bear a "Contains: milk" advisory in the correct format.
Voluntary / mandated
Voluntary: Firm initiated
Product description
NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads "Contains ingredients derived from dairy" under Recommended Use.
Distribution pattern
Product was manufactured and distributed to Multi level Marketing firm, NIKKEN WELLNESS
Recall initiation date
Sep 26, 2019
Initial firm notification
E-Mail
Center classification date
Oct 23, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0069-2020, published Oct 30, 2019. View the source record (openFDA) · FDA enforcement reports

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

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