Baidyanath brand Rajahpravartini Bati, Dietary Supplement, 80 Tablets -- Product of…
Butala Emporium, Inc. recalled this product and the FDA reported the enforcement action on 5 April 2017 as Class I. The recall was initiated by the firm. The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits .
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
- Baidyanath brand Rajahpravartini Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
- Reason for recall
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits .
- Recalling firm
- Butala Emporium, Inc.
- Firm location
- Jackson Heights, New York, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-1810-2017
- Quantity
- 120 bottles
- Distribution
- NY (via 3 retail stores) and directly to 26 individual consumers (CT, FL, HI, NJ, PA, OH, MA, District of Columbia, VT & PR)
- Initiated
- 27 August 2015
- Reported by FDA
- 5 April 2017
- Terminated
- 13 June 2018
- Firm notified by
- Telephone
- Product codes
- Batch No. 1) RAJ-15 & 2) 126, Expiry Date 1) 01/2019 & 2) 07/2016
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 is one of 10 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 10 separate recalls, which almost every published figure does, overstates it by a factor of 10. All 10 of them are listed on this page.
- The recall ran for 2.8 years, from 27 August 2015 to termination on 13 June 2018. 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 6 states, and the FDA published the enforcement report 19 months after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was longer 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: Florida, Hawaii, New Jersey, Pennsylvania, Ohio, Massachusetts. 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
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical 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 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 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 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
Filed under dietary supplements. A product can sit in more than one.
Every product in this recall
The FDA opened 10 enforcement records for this one recall, one per product code. This page carries all of them; the 9 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
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 Butala Emporium, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 9 other records name this firm.
All 10 records for Butala Emporium, Inc.
All 2017 recalls · All FDA food recall data
21 CFR 117.35(b) 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.