Mega Jex, Capsules

GM Manufacturing Inc. recalled this product and the FDA reported the enforcement action on 6 August 2014 as Class II. The recall was initiated by the firm. GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.

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

Mega Jex, Capsules

Reason for recall

GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.

Recalling firm

GM Manufacturing Inc.

Firm location

Gardena, California, United States

Classification

Class II

Status

Terminated

Recall number

F-2273-2014

Quantity

51,120 units

Distribution

CA

Initiated

3 July 2014

Reported by FDA

6 August 2014

Terminated

16 September 2014

Firm notified by

Letter

Product codes

12/11/12 > 12/12/12 4/30/13 > 5/1/13 12/13/13 > 12/17/13

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 46 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 46 separate recalls, which almost every published figure does, overstates it by a factor of 46. 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 46 of them.
• The recall ran for 2 months, from 3 July 2014 to termination on 16 September 2014. 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 5 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.

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 GM Manufacturing Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 45 other records name this firm.

All 46 records for GM Manufacturing Inc.

All 2014 recalls · All FDA food recall data