ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309…
ActiPharma, Inc. recalled this product and the FDA reported the enforcement action on 29 November 2023 as Class III. The recall was initiated by the firm. FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.
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
- ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
- UPC
- 363102217104
- Reason for recall
- FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.
- Recalling firm
- ActiPharma, Inc.
- Firm location
- Guaynabo, Puerto Rico, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0463-2024
- Quantity
- 607 bottles of 100 tablets each
- Distribution
- Domestic distribution, in Puerto Rico.
- Initiated
- 28 September 2023
- Reported by FDA
- 29 November 2023
- Terminated
- 16 January 2024
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot 13309, Exp: 01/26
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 4 months, from 28 September 2023 to termination on 16 January 2024. 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 2 months 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.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2023 recalls · All FDA food recall data
Behind every recall is a clause 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.