D-0908-2016 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2016
- Initiation Date
- January 15, 2016
- Termination Date
- February 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6024 bottles
Product Description
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 Pattern
Nationwide
Code Information
all lots