Drug & medication recalls High risk

Licorice Coughing Liquid recalled over undeclared morphine

Recall date
January 15, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Master Herbs, Inc./Li recalls Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Gr…
Recall number
D-0908-2016
FDA classification
Class I
Brand / firm
Master Herbs, Inc./Li
Sold / distributed
Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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