SOLGAR ENHANCED SERIES ABC DOPHILUS POWDER FOR INFANTS AND CHILDREN, NET WT.
NBTY, Inc. recalled this product and the FDA reported the enforcement action on 24 December 2014 as Class I. The recall was initiated by the firm. NBTY has recalled ABC Dophlius Powder due to the presense of Rhizopus oryzae fungi.
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
- SOLGAR ENHANCED SERIES ABC DOPHILUS POWDER FOR INFANTS AND CHILDREN, NET WT. 1.75 oz (50 g), UPC 0 33984 00010 0. Carefully Manufactured by: Solgar, Inc., 500 Willow Tree Road Leonia, NJ 07605 U.S.A.
- UPC
- 033984000100
- Reason for recall
- NBTY has recalled ABC Dophlius Powder due to the presense of Rhizopus oryzae fungi.
- Recalling firm
- NBTY, Inc.
- Firm location
- Bohemia, New York, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0710-2015
- Quantity
- 3,183 bottles
- Distribution
- AL, AR, AZ, CA, CT, CO, FL, IA, IL, IN, MI, ME, MO, MA, NC, NE, NY, NJ, NV, OH, OK, PA, PR, UT, TN, TX, VT, KY, WI, WA, United Kingdom and Israel
- Initiated
- 14 November 2014
- Reported by FDA
- 24 December 2014
- Terminated
- 9 May 2017
- Firm notified by
- Press Release
- Product codes
- Lot numbers: 074024-01, 074024-01R1 and 074024-02 Expiration Date: 7/31/15
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 14 November 2014 to termination on 9 May 2017. 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 30 states, and the FDA published the enforcement report 6 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.
Named in the distribution pattern: Alabama, Arkansas, Arizona, California, Connecticut, Colorado, Florida, Iowa, Illinois, Indiana, Michigan, Maine, Missouri, Massachusetts, North Carolina, Nebraska, New York, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Utah, Tennessee, Texas, Vermont, Kentucky, Wisconsin, Washington. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
Other records from NBTY, Inc.
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 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.