AquaLyte, 30g pkg./foil pouch, SKU: 1023

Basic Reset Inc. recalled this product and the FDA reported the enforcement action on 27 November 2019 as Class II. The recall was mandated. Products do not conform to Dietary Supplement CGMP regulations.

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

AquaLyte, 30g pkg./foil pouch, SKU: 1023

Reason for recall

Products do not conform to Dietary Supplement CGMP regulations.

Recalling firm

Basic Reset Inc.

Firm location

Hendersonville, Tennessee, United States

Classification

Class II

Status

Terminated

Recall number

F-0179-2020

Quantity

N/A

Distribution

Product was shipped to all 50 states. Product was shipped to the following foreign consignees: Canada, Nigeria, U.K., Australia, Israel, Puerto Rico, Virgin Islands, Hungary, UAE, Mexico, Philippines, Greece, and Puerto Rico.

Initiated

23 September 2019

Reported by FDA

27 November 2019

Terminated

19 August 2020

Firm notified by

E-Mail

Product codes

91117

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.
• This recall was not recorded as firm-initiated. The circumstances in which the FDA requests a recall are set out in 21 CFR 7.45.
• This is one of 14 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 14 separate recalls, which almost every published figure does, overstates it by a factor of 14. 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 14 of them.
• The recall ran for 11 months, from 23 September 2019 to termination on 19 August 2020. 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.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Other records from Basic Reset Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 13 other records name this firm.

All 14 records for Basic Reset Inc.

All 2019 recalls · All FDA food recall data