100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
Summary
The FDA issued a Class II for 100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glas by Vitality Works, Inc. Reason: Foreign material: pieces of a pen (writing utensil)..
Details
Source
Food Recall
External ID
F-1550-2023
Action Date
2023-10-04
Status
Terminated
Category
food
Product Description
100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
Lot/Code Info: Lot 2023-06871 (Lot numbers are generated by our ERP system and use the 4-digit year followed by a 5-digit sequential number.) Expires: 07/2028 Bottom Code: FENUGRK PCAP 202306871 EXP 07/28
Quantity Affected: 1,025 bottles (total)
Reason for Recall
Foreign material: pieces of a pen (writing utensil).
Distribution
55 Retail customers, representing 284 individual stores. All customers are located within the United States. There is no foreign distribution. There is no distribution to US Government agencies or departments. Distribution is by small parcel shipper (UPS, FedEx). Distribution Chain Notification Date: August 24, 2023
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-22
Company
Albuquerque, NM
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Vitality Works, Inc has 54 FDA actions in our database, including 54 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Vitality Works, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vitality Works, Inc have FDA actions?
Vitality Works, Inc has 54 FDA actions in our database, including 54 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1550-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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