FDA Drug Recalls

Recalls / Class II

Class IID-1352-2016

Product

PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.

Affected lot / code info
All lots

Why it was recalled

Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.

Recalling firm

Firm
Murray International Trading Co., Inc.
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
908 Dean St, Brooklyn, New York 11238-3204

Distribution

Quantity
Unknown
Distribution pattern
Nationwide and Puerto Rico

Timeline

Recall initiated
2016-04-20
FDA classified
2016-07-11
Posted by FDA
2016-07-20
Terminated
2018-06-14
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1352-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.