Drug 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
D-0908-2016
Product summary
- Event
- Event 73102
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6024 bottles
- Official record key
drug-enforcement:D-0908-2016
Official wording
Reason: Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
Code information: all lots
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.