MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product…
NBTY Inc. recalled this product and the FDA reported the enforcement action on 13 February 2013 as Class III. The recall was initiated by the firm. Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage.
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
- MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product Number 50390 (Bulk number 50389), UPC 7 86560 50389 1, Label Revision 00B --- Manufactured in the USA by MET-RX Nutrition, Inc. Boca Raton, FL 33487
- UPC
- 786560503891
- Reason for recall
- Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage.
- Recalling firm
- NBTY Inc.
- Firm location
- Bohemia, New York, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0980-2013
- Quantity
- 40,668 bottles (shipped and sold in cases of 12)
- Distribution
- Nationwide and Puerto Rico
- Initiated
- 21 December 2012
- Reported by FDA
- 13 February 2013
- Terminated
- 18 May 2016
- Firm notified by
- Letter
- Product codes
- Lot # 430855, Expiration Date 12/21/12; Lot # 430856, Expiration Date 12/29/12
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. 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 2 of them.
- The recall ran for 3.4 years, from 21 December 2012 to termination on 18 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 FDA published the enforcement report 8 weeks 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.
What this recall was for
Spoilage and mould
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.93
- Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
- 21 CFR 117.80(b)(3)
- Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. 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 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 2013 recalls · All FDA food recall data
21 CFR 117.93 is the clause behind this recall, and it is one 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.