Reumofan Plus: Recall – Undeclared Drug Ingredient
February 19, 2013
Audience: Consumer, Health Professional, Emergency Medicine
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. One illness has been reported to date in connection with this problem.
Samantha Lynn Inc. is voluntarily recalling 500 lots of Reumofan Plus Tablets to the consumer level due to findings of undeclared drug ingredients. The FDA sample analysis has found the product to contain methocarbamol and diclofenac. The affected Reumofan Plus lots may include the following lot number(s): 99515 ex096 and expires: 2016. The product is marketed in a green bottle…
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