Recalls / Class I
Class IF-1812-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.
Product
Baidyanath brand Shankh Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
- Type
- Food
- Affected lot / code info
- Batch No. SHN-02, Expiry Date 08/2018
- Quantity
- 422 bottles
Why it was recalled
The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
Recalling firm
- Firm
- Butala Emporium, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 3746 74th St, Jackson Heights, New York 11372-6338
Distribution
- Distribution pattern
- NY (via 3 retail stores) and directly to 26 individual consumers (CT, FL, HI, NJ, PA, OH, MA, District of Columbia, VT & PR)
Timeline
- Recall initiated
- 2015-08-27
- FDA classified
- 2017-03-30
- Posted by FDA
- 2017-04-05
- Terminated
- 2018-06-13
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1812-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.