Licorice Coughing Liquid Recalled for Undeclared Morphine
Master Herbs is recalling Licorice Coughing Liquid because it contains undeclared morphine and was marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric. Additionally, the presence of undeclared morphine in an OTC product represents a critical safety hazard.
Plain-English summary
Master Herbs, Inc. is recalling Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC. The product is manufactured by Ma Ying Long Pharmaceutical Group Co., LTD in Wuhan, China, and distributed by Master Herbs (USA) Inc. The recall involves 6,024 bottles and is distributed nationwide.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared morphine. The source text does not specify which lots are affected, though the structured metadata indicates 'all lots'.
Consumers should stop using the product and contact the recalling firm for instructions on how to return it or obtain a refund.
The recalled product
- 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
- Manufacturer
- Master Herbs, Inc./Li
- Category
- Drug — OTC Cough Medicine
- Affected units
- 6,024
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
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