Innate Response Digestive Enzymes Clinical Strength 90ct. (40126) and " Innate Response…

FoodState (Nutrient Manufacturing) recalled this product and the FDA reported the enforcement action on 1 January 2014 as Class II. The recall was initiated by the firm. Potential for Chloramphenicol contamination.

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

Innate Response Digestive Enzymes Clinical Strength 90ct. (40126) and " Innate Response Digestive Enzymes Clinical Strength 10 Ct. Sample (90037)

Reason for recall

Potential for Chloramphenicol contamination.

Recalling firm

FoodState (Nutrient Manufacturing)

Firm location

Londonderry, New Hampshire, United States

Classification

Class II

Status

Terminated

Recall number

F-1135-2014

Quantity

20661

Distribution

Nationwide Foreign:

Initiated

12 November 2013

Reported by FDA

1 January 2014

Terminated

30 June 2014

Firm notified by

Telephone

Product codes

Lot Numbers: 10841 11040 11057 11184 11185 11639 11690 12105 12106 12202 12445 12547 13546 14626 14627 14767 14981 15650 D239

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 6 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 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. All 6 of them are listed on this page.
• The recall ran for 8 months, from 12 November 2013 to termination on 30 June 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 FDA published the enforcement report 7 weeks 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.

Every product in this recall

The FDA opened 6 enforcement records for this one recall, one per product code. This page carries all of them; the 5 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

Other records from FoodState (Nutrient Manufacturing)

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.

All 6 records for FoodState (Nutrient Manufacturing)

All 2014 recalls · All FDA food recall data