PlainRecalls
FDA Drug Moderate Class II Terminated

PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.

Reported: July 20, 2016 Initiated: April 20, 2016 #D-1345-2016

Product Description

PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.

Reason for Recall

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

Details

Units Affected
84 bottles
Distribution
Nationwide and Puerto Rico
Location
Brooklyn, NY

Frequently Asked Questions

What product was recalled?
PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.. Recalled by Murray International Trading Co., Inc.. Units affected: 84 bottles.
Why was this product recalled?
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 20, 2016. Severity: Moderate. Recall number: D-1345-2016.