Liposomal Magnesium Nutritional Supplement. 6 FL. OZ (180 ml) The product is packaged in…
Empirical Laboratories, Incorporated recalled this product and the FDA reported the enforcement action on 25 May 2016 as Class II. The recall was initiated by the firm. Empirical Labs is recalling Liposomal Magnesium because of the potential for mold contamination.
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
- Liposomal Magnesium Nutritional Supplement. 6 FL. OZ (180 ml) The product is packaged in a six ounce, plastic, Royalty Bottle, with a 24mm vented flip top lid. item number: DES004Z. Sold under brands DESBIO and Seeking Health
- Reason for recall
- Empirical Labs is recalling Liposomal Magnesium because of the potential for mold contamination.
- Recalling firm
- Empirical Laboratories, Incorporated
- Firm location
- Fort Collins, Colorado, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1366-2016
- Quantity
- 1972 bottles
- Distribution
- Nationwide. No foreign or govt/VA/military consignees.
- Initiated
- 5 April 2016
- Reported by FDA
- 25 May 2016
- Terminated
- 17 May 2017
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot Number: 5101206 and 5111003
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 13 months, from 5 April 2016 to termination on 17 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 1 state, and the FDA published the enforcement report 7 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was about typical 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 Empirical Laboratories, Incorporated
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 13 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2013-11-20 | All-Natural Greens Dietary Supplement; Manufactured Exclusively for NatureRich, Maple Grove, MN 55369. | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Empirical Labs Building Health SuperFuel Tropical Dietary Supplement | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Dynamite Specialty Products Tri-Mins Daily Foundation, calcium, magnesium, potassium dietary supplement; 240 Capsules; Manufactured for Dynamite Marketing, Inc, Meridian, ID 83642. | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Empirical Labs Building Health SuperFuel Plus Mocha Flavor; Whey protein isolate (milk); Dietary Supplement | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Non-GMO Ingredients Go Green Fuel for the Entire Body Dietary Supplement. All-Natural Greens Dietary Supplement. Manufactured Exclusiveley for: Hsin Ten Enterprise USA, Inc. Industry, CA 91748. | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Empirical Labs Building Health Inte-Zyme; 180 Capsules Dietary Supplement | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Empirical Labs Building Health P&L Enzymes; 180 Capsules Dietary Supplement | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Empirical Labs Building Health Vascuzyme; 90 Capsules Dietary Supplement | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Empirical Labs Building Health Digesti-Zyme; 180 Capsules Dietary SupplementSupplement | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
| 2013-11-20 | Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness. | Empirical Laboratories, Incorporated | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. | Class II |
All 14 records for Empirical Laboratories, Incorporated
All 2016 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.