FDA recall D-0908-2016

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 for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-01-15

Report date

2016-06-01

Termination date

2017-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pomona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0908-2016