L-Carnitine, labeled in part as "Healthy Life Chemistry" By Purity First, Est.
Mira Health Products Ltd. recalled this product and the FDA reported the enforcement action on 8 January 2014 as Class II. The recall was initiated by the firm. The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.
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
- L-Carnitine, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (90 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.
- Reason for recall
- The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.
- Recalling firm
- Mira Health Products Ltd.
- Firm location
- Farmingdale, New York, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1290-2014
- Quantity
- unknown
- Distribution
- GA, FL, NC, possibly NJ and New Zealand
- Initiated
- 4 September 2013
- Reported by FDA
- 8 January 2014
- Terminated
- 26 November 2014
- Firm notified by
- Letter
- Product codes
- All lots within expiry and distributed prior to August 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 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 79 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 79 separate recalls, which almost every published figure does, overstates it by a factor of 79. 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 79 of them.
- The recall ran for 15 months, from 4 September 2013 to termination on 26 November 2014. 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 3 states, and the FDA published the enforcement report 4 months 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.
Named in the distribution pattern: Georgia, Florida, North Carolina. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Undeclared allergens
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen 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 117.135(c)(2)
- Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
- 21 CFR 101.4
- Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Unapproved ingredients
An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.
A preventive controls plan covers an unapproved ingredient 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 111
- Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
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 Mira Health Products Ltd.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 79 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2014-02-19 | Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle). | Mira Health Products Ltd. | Mira Health Products Ltd. recalled products marked as Dietary Supplements due to the use of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract in their raw materials. | Class II |
| 2014-01-08 | Nature Science Alpha Male capsules, packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Nature Science Super Drol capsules, packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Biogenix USA Decadrol capsules, packaged in plastic bottles with 90 capsules per bottle and also packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Biogenix USA Sports A-Acid capsules, packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Biogenix USA Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Nisha Power Pill capsules packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Biogenix USA E-Control capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Vitamin C, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
| 2014-01-08 | Biogenix USA Alpha Male capsules, packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. | Class II |
All 80 records for Mira Health Products Ltd.
All 2014 recalls · All FDA food recall data
21 CFR 117.135(c)(2) 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.