Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle).

Mira Health Products Ltd. recalled this product and the FDA reported the enforcement action on 19 February 2014 as Class II. The recall was initiated by the firm. Mira Health Products Ltd. recalled products marked as Dietary Supplements due to the use of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract in their raw materials.

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

Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle).

Reason for recall

Mira Health Products Ltd. recalled products marked as Dietary Supplements due to the use of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract in their raw materials.

Recalling firm

Mira Health Products Ltd.

Firm location

Farmingdale, New York, United States

Classification

Class II

Status

Terminated

Recall number

F-1473-2014

Quantity

unknown (firm did not maintain accurate consistent logs)

Distribution

GA

Initiated

23 July 2013

Reported by FDA

19 February 2014

Terminated

22 May 2018

Firm notified by

Letter

Product codes

lot J53Q

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 4.8 years, from 23 July 2013 to termination on 22 May 2018. 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 1 state, and the FDA published the enforcement report 7 months after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was longer 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.

Other records from Mira Health Products Ltd.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 79 other records name this firm.

All 80 records for Mira Health Products Ltd.

All 2014 recalls · All FDA food recall data