Muscle Milk 14 oz., 25 g protein Strawberry; UPC (case): 8-76063-00229-5; UPC (unit)…
H.P. Hood, LLC recalled this product and the FDA reported the enforcement action on 16 November 2016 as Class II. The recall was initiated by the firm. Products recalled due to premature spoilage (swelled containers & foul odor).
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
Muscle Milk 14 oz., 25 g protein Strawberry; UPC (case): 8-76063-00229-5; UPC (unit): 8-76063-00209-7
Reason for recall
Products recalled due to premature spoilage (swelled containers & foul odor).
HP Hood lot numbers: C16011, D16012, C16051, I15352, I16104, F16136 A16137.
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 18 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 18 separate recalls, which almost every published figure does, overstates it by a factor of 18. 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 18 of them.
The recall ran for 8 months, from 9 June 2016 to termination on 13 February 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 FDA published the enforcement report 5 months after the firm began the recall.
Recalls of milk or a dairy product run a median of 7 months, so this one was longer than usual for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
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.
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.
This recall has been initiated because a contamination event downstream of the thermal process deemed the product not commercially sterile and creates the potential for product spoilage.
Class II
Other records from H.P. Hood, LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 17 other records name this firm.
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.
Recall 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.
