Licorice Coughing Liquid (guaifenesin)…

Date

June 1, 2016

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

Master Herbs, Inc./Li

Product

Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01

Reason

Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.

Distribution pattern

Nationwide

Quantity

6024 bottles

Codes and lots

all lots

Recall started

Jan. 15, 2016

Recall number

D-0908-2016

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0908-2016. The agency record governs; check it and the company before acting.