FDA Recall D-0908-2016
Master Herbs, Inc./Li · Pomona, CA
Class I — life-threatening Terminated 389 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0908-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2016-01-15
- Classified by FDA Center
- 2016-05-26
- FDA published
- 2016-06-01
- Terminated
- 2017-02-07
- Recalling firm
- Master Herbs, Inc./Li
- Firm location
- Pomona, CA