New #dietary #supplement #drug #recall due to elevated levels of Lead & Mercury

Butala Emporium, Inc. Recalls Eleven Ayurvedic Dietary Supplements Because of Elevated Levels of Lead and Mercury

Contact:
Consumer:
Shaswat Butala
718-899-5590
FOR IMMEDIATE RELEASE — September 15, 2015 — Jackson Heights, NY — Butala Emporium, Inc of Jackson Heights, NY, is voluntarily recalling eleven Ayurvedic (dietary) supplements (listed below) because the products were found to contain elevated lead and mercury levels which may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders if consumed.The concentration of lead exceeds the recommended daily lead exposure for children less than 6 years of age and women of childbearing age and would likely be injurious to health. If a child or a pregnant woman is exposed to lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system, learning disorders, developmental defects, and other long-term health problems can occur. The problems that might occur are dependent on the duration and degree of exposure.

The mercury levels in these products are high and exceed the weekly intake exposure and would likely be injurious to health. The elevated mercury levels in these products with short term use can cause kidney, stomach and intestinal (or gut) symptoms, while month-long use of these products could be potentially lethal. Mercury consumption at these levels can also cause psychiatric and personality disturbances, ataxia (or loss of coordination), visual loss, hearing loss, and other neurological conditions particularly exposed in utero. Butala is notifying individuals not to consume this product.

Baidyanath brand Saptamrit Lauh--Batch No. SPL-04, Expiry Date 4/2018
Baidyanath brand Rajahpravartini Bati--Batch No. RAJ-15 0 & 126, Expiry Date 1/2019 & 07/2016
Baidyanath brand Sarivadi Bati--Batch No. SRI-09, Expiry Date 04/2018
Baidyanath brand Shankh Bati--Batch No. SHN-02, Expiry Date 08/2018
Baidyanath brand Marichyadi Bati--Batch No. 200, Expiry Date 08/2017
Baidyanath brand Agnitundi Bati--Batch No. 018, Expiry Date 02/2016
Baidyanath brand Arogyavardhini Bati--Batch No. 018, Expiry Date 03/2017
Baidyanath brand Sarivadi Bati--Batch No. SARI-015, Expiry Date 01/2019
Baidyanath brand Brahmi Bati--Batch No. HGB-18, Expiry Date 03/2019, Batch Nos. 244 & 242, Expiry Date 03/2017 (products without Batch No. or Expiry Date are subject to this recall)
Baidyanath brand Gaisantak Bati--Batch No. GAI-09, Expiry Date 08/2018 and Batch No. 141, Expiry Date 10/2017
Baidyanath brand Chitrakadi Bati--Batch No. 193, Expiry Date 02/2018

The 80-count-capsules are packed in white, plastic bottles with green, yellow or orange labeling under the brand name “Baidyanath” made by Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane,  Kolkata, India and top cap sticker with imported by Butala Emporium

The product was distributed in NY through retail stores and to consumers as single unit purchases via the firms internet site within CA, CT, FL, HI, MA, NJ, OH, PA, VT, D.C. and PR).

No complaints or illnesses have been received to date.

The recall was initiated after it was discovered that the products contain high levels of lead and mercury based on NYC Department of Health laboratory and U.S. Food and Drug Administrating testing.

Pregnant women and patients with underlying kidney problems who may have consumed any of the above products should consult with their physician or health care provider.  For more information, consumers should contact their local poisoning prevention program or local public health department.

Consumers who have purchased these products are urged not to consume the product and should return them to the place of purchase for a full refund.  Consumers with questions may contact the company at 1-718-899-5590, Monday – Friday, 9 am – 5 pm ET or email butala1@aol.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178