Nature's Way,UPC 33674150900, Alive Whole Food Energizer MultiVitamin 90 Vcaps, 20009817

Schwabe North America, Inc. recalled this product and the FDA reported the enforcement action on 25 December 2013 as Class II. The recall was initiated by the firm. Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.

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

Nature's Way,UPC 33674150900, Alive Whole Food Energizer MultiVitamin 90 Vcaps, 20009817

UPC

33674150900

Reason for recall

Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.

Recalling firm

Schwabe North America, Inc.

Firm location

Green Bay, Wisconsin, United States

Classification

Class II

Status

Terminated

Recall number

F-0833-2014

Quantity

1500

Distribution

US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: South Korea, Ghana, Romania and Singapore.

Initiated

23 October 2013

Reported by FDA

25 December 2013

Terminated

26 February 2015

Firm notified by

Letter

Product codes

20009817

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 13 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 13 separate recalls, which almost every published figure does, overstates it by a factor of 13. 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 13 of them.
• The recall ran for 16 months, from 23 October 2013 to termination on 26 February 2015. 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 45 states, and the FDA published the enforcement report 2 months after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was about typical 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: Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia. 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 Schwabe North America, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 12 other records name this firm.

All 13 records for Schwabe North America, Inc.

All 2013 recalls · All FDA food recall data