Summary
The FDA issued a Class I for Dube Ortho & PT 144 Bottles Capsules 60ct No UPC CODE by NutraCap Labs LLC. Reason: During an FDA investigation the firm was notified that the product contains undeclared shellfish..
Details
Source
Food Recall
External ID
F-0430-2022
Action Date
2022-01-19
Status
Terminated
Category
food
Product Description
Dube Ortho & PT 144 Bottles Capsules 60ct No UPC CODE
Lot/Code Info: LOT #2006159 EXP DATE 06/2022 LOT #2012121 EXP DATE 12/2022
Quantity Affected: 80,169 various bottles and jars
Reason for Recall
During an FDA investigation the firm was notified that the product contains undeclared shellfish.
Distribution
Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MN, NC, NJ, NV, NY, OH, OR, SC, TN, TX, VA & WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-09
Company
Norcross, GA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 146 food recalls issued in the same week, part of 204 food-related FDA actions this month.
NutraCap Labs LLC has 106 FDA actions in our database, including 106 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NutraCap Labs LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NutraCap Labs LLC have FDA actions?
NutraCap Labs LLC has 106 FDA actions in our database, including 106 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0430-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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