Butala Emporium Inc., of Jackson Heights, NY, is voluntarily recalling 11 Ayurvedic (dietary) supplements (listed below) because the products were found to contain elevated lead and mercury levels which, if consumed, may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders. The products were distributed in NY through retail stores and to consumers as single-unit purchases via the firm’s Internet site within CA, CT, FL, HI, MA, NJ, OH, PA, VT, Washington, D.C., and PR. The recall was initiated after it was discovered that the products contain high levels of lead and mercury based on testing by the New York City Department of Health laboratory and the U.S. Food and Drug Administration (FDA). No complaints or illnesses have been received to date. The concentration of lead exceeds the recommended daily lead exposure for children younger 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 these products: 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. 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 poison prevention program or local public health department. Consumers who have purchased these products are urged not to consume them 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 through Friday, 9 a.m. to 5 p.m. ET or email to email@example.com. Adverse reactions or quality problems experienced with the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Online: Complete and submit the report here.
- Regular Mail or Fax: Download the form here, or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form, or submit it via fax to 1-800-FDA-0178.
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