sábado, 16 de enero de 2016

FDA MedWatch - Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine

AUDIENCE: Consumer, Pharmacy
ISSUE: The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine. The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine,  consumers who are hypersensitive to morphine could suffer severe allergic reactions if they take this product. Other effects of morphine can include, but are not limited to, respiratory depression and death.
BACKGROUND: This product is manufactured by Ma Ying Long Pharmaceutical Group in China and distributed in the U.S. by Master Herbs USA, Inc. in Pomona, CA. The distributor has agreed to recall the product. This product is available on-line and in some retail stores.
RECOMMENDATION: Consumers should not purchase this cough syrup and anyone who has this product should not use it.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the CDER Alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm482100.htm

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