Digestive enzyme capsules sold under the NOW Foods, Beeyoutiful, Best in Nature…
NOW Foods recalled this product and the FDA reported the enforcement action on 26 February 2014 as Class II. The recall was initiated by the firm. Digestive enzyme capsules manufactured by NOW Foods 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
- Digestive enzyme capsules sold under the NOW Foods, Beeyoutiful, Best in Nature, Bluegrass Naturals Vitamin Company, Chicago Nutrition Company, Gluten-Free Remedies, Osa's Garden, and Professional Naturopathics brands and packaged in a plastic bottle containing 60 or 120 capsules.
- Reason for recall
- Digestive enzyme capsules manufactured by NOW Foods may contain the antibiotic chloramphenicol.
- Recalling firm
- NOW Foods
- Firm location
- Bloomingdale, Illinois, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1537-2014
- Quantity
- 31,344 bottles
- Distribution
- US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia; FOREIGN: Bulgaria, China, Germany, Greece, Romania, Singapore, Slovakia, United Kingdom
- Initiated
- 7 November 2013
- Reported by FDA
- 26 February 2014
- Terminated
- 16 May 2016
- Firm notified by
- Letter
- Product codes
- *** 1) Product Code 2965; Lot Numbers: 1660276, 1653504, 1634330, 1618025, 1606053, 1587905, 1539085, 1518136, 1497964, 1476818. *** 2) Product Code 2968; Lot Numbers: 1645219, 1630289, 1616607, 1607295, 1593903, 1549088, 1536759, 1528258, 1516482, 1511273, 1483789, 1470001, 1458643. *** 3) Product Code 102965; Lot Numbers: 1649254, 1643889, 1632228, 1630192, 1622153, 1618074, 1606601, 1599557, 1599554, 1571142. 1564422, 1554121, 1554086, 1548791, 1538088, 1538078, 1522374, 1520852, 1510332, 1498999, 1492855, 1479602, 1475604, 1459330. *** 4) Product Code: 102968; Lot Numbers 1620846, 1534791. *** 5) Product Code 3C212965; Lot Number: 1602054
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 2.5 years, from 7 November 2013 to termination on 16 May 2016. 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 46 states, and the FDA published the enforcement report 4 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.
Named in the distribution pattern: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, 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 NOW Foods
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 2014 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.