100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer…
Vitality Works, Inc recalled this product and the FDA reported the enforcement action on 4 October 2023 as Class II. The recall was initiated by the firm. Foreign material: pieces of a pen (writing utensil).
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- 100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
- Reason for recall
- Foreign material: pieces of a pen (writing utensil).
- Recalling firm
- Vitality Works, Inc
- Firm location
- Albuquerque, New Mexico, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1584-2023
- Quantity
- 1,025 bottles (total)
- 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
- Initiated
- 22 August 2023
- Reported by FDA
- 4 October 2023
- Terminated
- 13 November 2023
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- 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
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 54 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 54 separate recalls, which almost every published figure does, overstates it by a factor of 54. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 54 of them.
- The recall ran for 3 months, from 22 August 2023 to termination on 13 November 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 6 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
What this recall was for
Foreign material
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.40
- Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
- 21 CFR 117.80(c)
- Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
- 21 CFR 117.150
- Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Vitality Works, Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 53 other records name this firm.
All 54 records for Vitality Works, Inc
All 2023 recalls · All FDA food recall data
21 CFR 117.40 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.