Lupin Pharmaceuticals Inc. is recalling 3,216 bottles (120-count) of Zileuton Extended-Release Tablets, 600 mg. The recall was initiated after dissolution testing during a stability study showed that the tablets did not meet quality standards. If the medication does not dissolve properly, the patient may not receive the intended therapeutic dose of the drug. Zileuton is a prescription medication used to prevent and treat asthma symptoms; no injuries or incidents have been reported to date.
The failure to meet dissolution specifications means the medication may not be absorbed by the body at the correct rate or amount. This could lead to a lack of effectiveness in managing asthma, although no adverse events have been reported.
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Manufactured for Lupin Pharmaceuticals, Inc. by Lupin Limited, India.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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