Smartypants Kids Complete, Non GMO Multi and omega 3's vitamin D3 for bones, vitamin B12…
Smartypants Vitamins recalled this product and the FDA reported the enforcement action on 12 December 2018 as Class II. The recall was initiated by the firm. Consumer complaints of finding foreign objects in bottles of gummy vitamins.
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
- Smartypants Kids Complete, Non GMO Multi and omega 3's vitamin D3 for bones, vitamin B12 for Energy: 90 gummies. UPC 8 5136 00425 5 Distributed by SmartyPants Inc., Marina del Rey, CA 90292
- UPC
- 85136004255
- Reason for recall
- Consumer complaints of finding foreign objects in bottles of gummy vitamins.
- Recalling firm
- Smartypants Vitamins
- Firm location
- Marina Del Rey, California, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0683-2019
- Quantity
- 60,726 bottles
- Distribution
- WA, IL, RI, MC, NJ, ID, IA, VA, NY, OH, CA, NC.
- Initiated
- 13 November 2018
- Reported by FDA
- 12 December 2018
- Terminated
- 27 June 2019
- Firm notified by
- Letter
- Product codes
- KC90-MH8C09: Expiration date: 08SEP2019
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 7 months, from 13 November 2018 to termination on 27 June 2019. 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 11 states, and the FDA published the enforcement report 4 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter 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.
Named in the distribution pattern: Washington, Illinois, Rhode Island, New Jersey, Idaho, Iowa, Virginia, New York, Ohio, California, 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
Foreign material
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material 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 117.40
- Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
- 21 CFR 117.80(c)
- Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
- 21 CFR 117.150
- Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
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.
All 2018 recalls · All FDA food recall data
21 CFR 117.40 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.