Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian…

ProThera, Inc. dba SFI USA recalled this product and the FDA reported the enforcement action on 3 April 2019 as Class II. The recall was initiated by the firm. Mis-packaging; product is labeled as Reduce L-Glutathione but actually contains Lithium Orotate.

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

Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9

Reason for recall

Mis-packaging; product is labeled as Reduce L-Glutathione but actually contains Lithium Orotate.

Recalling firm

ProThera, Inc. dba SFI USA

Firm location

Reno, Nevada, United States

Classification

Class II

Status

Terminated

Recall number

F-1186-2019

Quantity

139 bottles

Distribution

US distribution to the following: AL, AZ, CA, KS, LA, MI, MO, NH, NJ, NY, OR, PA, TX, and WA Foreign distribution to the following: Netherlands, Great Britain, and Korea

Initiated

13 December 2018

Reported by FDA

3 April 2019

Terminated

2 April 2019

Firm notified by

Letter

Product codes

FG Lot: 2018210303 Expiration: 05/2020

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 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 13 December 2018 to termination on 2 April 2019. 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 distribution pattern names 12 states, and the FDA published the enforcement report 4 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.

Named in the distribution pattern: Arizona, California, Kansas, Louisiana, Michigan, Missouri, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Texas. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

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.

Other records from ProThera, Inc. dba SFI USA

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 2019 recalls · All FDA food recall data