Saba Shark Cartilage Complex Dietary Supplement, 500 mg, 60 Capsules, Distributed by…
AMS Health Sciences recalled this product and the FDA reported the enforcement action on 12 November 2014 as Class I. The recall was initiated by the firm. The product is being recalled due to the potential presence of Salmonella.
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
- Saba Shark Cartilage Complex Dietary Supplement, 500 mg, 60 Capsules, Distributed by Saba 711 NE 39th Street, Oklahoma City, OK 73105
- Reason for recall
- The product is being recalled due to the potential presence of Salmonella.
- Recalling firm
- AMS Health Sciences
- Firm location
- Oklahoma City, Oklahoma, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0462-2015
- Quantity
- 2,014 bottles
- Distribution
- Nationwide throughout the US and in Canada
- Initiated
- 15 October 2014
- Reported by FDA
- 12 November 2014
- Terminated
- 9 February 2016
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot number 416349, 08/16
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 16 months, from 15 October 2014 to termination on 9 February 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 4 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
Salmonella
Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.
A preventive controls plan covers Salmonella contamination 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)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 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.
- 21 CFR 117.165(a)(2)
- Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.
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 AMS Health Sciences
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2014-10-15 | saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105 | AMS Health Sciences | Product called SABA ACE (Appetite Control Energy) that was manufactured prior to September 2013 was found to have DMAA (1,3-Dimethylpentylamine) based on label and laboratory analysis. the DMAA was removed when the product was reformulated in September 2013. | Class II |
All 2014 recalls · All FDA food recall data
21 CFR 117.135(c)(1) 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.