Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Chemical Contamination; benzophenone leached from the product label varnish
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Compare with the code on your package — it is the most precise check available.
Drug: Felodipine
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Chemical Contamination; benzophenone leached from the product label varnish
Chemical Contamination; benzophenone leached from the product label varnish
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Chemical Contamination; benzophenone leached from the product label varnish
Chemical Contamination; benzophenone leached from the product label varnish
Chemical Contamination; benzophenone leached from the product label varnish
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