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Recall Reason:: The medication failed dissolution specifications, meaning it may not dissolve properly in the body, affecting its efficacy.
FDA Classification:: The FDA classified the recall as Class II, indicating a low risk of serious health consequences but potential temporary or reversible effects.
Affected Medications:: The recall includes multiple dosage levels (10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg) of lisdexamfetamine dimesylate capsules.
Why This Matters:: Patients may not be receiving the correct dose of medication, which could impact their ADHD management. It's crucial to check your medication and consult with your healthcare provider.
Sun Pharmaceutical Industries issued a nationwide recall of lisdexamfetamine dimesylate capsules after discovering that certain lots did not meet dissolution specifications. This means the medication might not break down properly in the body, potentially reducing its therapeutic effects. The FDA's Class II classification suggests that while the risk of serious adverse health consequences is low, patients may experience temporary or reversible issues due to the medication's reduced efficacy.
How to Prepare:
Check Your Medication: Verify if your lisdexamfetamine dimesylate capsules are included in the recalled lots. Refer to the list of recalled medications for specific lot numbers and expiration dates.
Contact Your Healthcare Provider or Pharmacy: If your medication is affected, contact your doctor or pharmacist for guidance on obtaining a replacement or refund.
Do Not Stop Medication Abruptly: Abruptly stopping ADHD medication can cause withdrawal symptoms. Consult your healthcare provider before making any changes to your treatment plan.
Who This Affects Most:
This recall primarily affects individuals with ADHD who rely on lisdexamfetamine dimesylate capsules to manage their symptoms. Children, adolescents, and adults taking this medication should check their prescriptions to ensure they are not affected.
Q: What does 'failed dissolution specifications' mean?
It means the drug did not dissolve as expected in laboratory settings, which could make it less effective.
Q: What should I do if my medication is part of the recall?
Contact your healthcare provider or pharmacy for guidance on obtaining a replacement or refund.
Check your lisdexamfetamine dimesylate capsules (generic Vyvanse) for the recalled lot numbers and expiration dates.
Contact your healthcare provider or pharmacy if your medication is affected.
Do not discontinue your medication without consulting your doctor.
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