PURE PROTEIN PROTEIN SHOT 25g PROTEIN, GRAPE Flavor PROTEIN DRINK 2.9 fl. oz.
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. Lactobacillus plantarum and Lactobacillus brevis were 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
- PURE PROTEIN PROTEIN SHOT 25g PROTEIN, GRAPE Flavor PROTEIN DRINK 2.9 fl. oz. (86 mL), Product Number 50451, Bulk Number 36753 (Vial), UPC 7 49826 50451 3 (Vial), and Product Number 50452, Bulk Number 36753 (Carton of 6), UPC 7 49826 50452 0 (Carton). --- Carefully Manufactured by Worldwide Sport Nutritional Supplements, Inc. Bayport, NY 11705
- UPC
- 749826504513
- Reason for recall
- Lactobacillus plantarum and Lactobacillus brevis were 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-0981-2013
- Quantity
- 61,866 vials (sold in cartons of 6)
- 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 # 406844, Expiration Date 04/03/2013; Lot # 439941, Expiration Date 07/26/2013; Lot # 445206, Expiration Date 10/31/2013; Lot # 456438, Expiration Date 11/30/2013
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. All 2 of them are listed on this page.
- 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 fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
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 fresh produce, dietary supplements and beverages and juice. A product can sit in more than one.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 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.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2013-02-13 | 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 | NBTY Inc. | Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. | Class III |
Other fresh produce 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.