MANILA, Philippines – The Food and Drug Administration (FDA) warned the public that it has ordered the recall of some batches of a pain-relieving drug due to possible health risks.
In Advisory No. 2015-85, the FDA said the recall of naproxen sodium 550-milligram tablets manufactured by Scheele Laboratories Phil. Inc. was due to “non-conformance on physical appearance of the subject product where brown spots were noted during production, specifically during the compression prior to blistering of the tablets.”
Naproxen sodium is used to treat ankylosing spondylitis, osteoarthritis and rheumatoid arthritis including juvenile arthritis. It is also used for dysmenorrheal headache, including migraine, post-operative pain, soft- tissue disorders, acute gout, and to reduce fever.?