FDAClass IIJuly 20, 2016

Tien Ma Tou Tong Wan recall: Labeling Error

Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.

Why was Tien Ma Tou Tong Wan recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots

Product
Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.
Recalling firm
Murray International Trading Co., Inc.
Quantity
96 bottles
Distribution
Nationwide and Puerto Rico
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls