Products found to contain undeclared medicines
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| The United States: Reumofan Plus USA, LLC & Reumofan USA, LLC is Voluntarily Recalling all lots of Reumofan Plus Tablets Due to Undeclared Drug Ingredients Methocarbamol, Dexamethasone, and Diclofenac |
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The Food and Drug Administration (FDA) announced that Reumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac. The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug. Use of this product could result in serious and life-threatening injuries. One illness has been reported to date in connection with this problem. Distribution of the product has been completely terminated by Reumofan Plus USA, LLC and Reumofan USA. Consumers that have Reumofan Plus should be aware that the product may pose a serious health risk. Consumers who are taking these products or who have recently stopped taking Reumofan Plus should immediately consult a healthcare professional.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm306360.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been released by FDA and was posted on the website of Drug Office on 2 June, 22 August, 29 August and 20 December 2012; and by MHRA and Health Canada, and was posted on the website of Drug Office on 18 October 2012 and 22 December 2012 respectively.
Ends/ Wednesday, February 20, 2013
Issued at HKT 12:00
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