Harvard Drug Group recalls 9mg paliperidone extended-release tablets with failed dissolution specs. Affected units have NDC 0904-6937-61 and specific lot numbers. Consumers should contact for remedy.
Failed Dissolution Specifications
Harvard Drug Group is recalling 9mg paliperidone extended-release tablets that failed dissolution tests. This means the medication may not work as intended, which could affect treatment effectiveness.
The tablets failed dissolution specifications, meaning they may not release medication properly in the body. This could lead to inconsistent dosing and treatment effectiveness, but does not cause immediate harm.
Prescription patients using the recalled 9mg paliperidone tablets. Those with mental health conditions requiring this medication are most at risk.
Check for NDC code 0904-6937-61 on the package. Look for lot numbers N00522 (expiring 09/2022) or N00618 (expiring 11/2022).
Look for NDC code 0904-6937-61 and lot numbers N00522 or N00618 on the package.
9mg paliperidone extended-release tablets, 100 tablets per carton (10 x 10 blister packs), prescription-only.
Check for NDC code 0904-6937-61 and lot numbers N00522 (expiring 09/2022) or N00618 (expiring 11/2022).
The recall record does not specify a remedy, so contact Harvard Drug Group for instructions.
We’ve drafted a message you can send The Harvard Drug Group to request your refund or repair — edit it as you like.
Subject: Recall D-0649-2022 — The Harvard Drug Group The Harvard Drug Group Hello, I own a The Harvard Drug Group that is covered by recall D-0649-2022 from The Harvard Drug Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
