Apotex recalls Risperidone Oral Solution (1 mg/mL, 30mL) due to impurity at 18-month stability. This may affect safety for patients using prescription medication.
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Apotex is recalling Risperidone Oral Solution (1 mg/mL, 30 mL bottle) because it failed impurity testing at the 18-month stability point. This could pose a safety risk for patients using this prescription medication.
The product failed impurity testing at the 18-month stability point, meaning it may contain harmful substances that could affect patient safety. This is a quality issue that could lead to health risks if the medication is used without proper testing.
Patients prescribed Risperidone Oral Solution by a healthcare provider. Those using the specific product with NDC 60505-0380-1 and lot number KD4855 are most at risk.
Check for the product name 'Risperidone Oral Solution', 1 mg/mL concentration, 30 mL bottle, and prescription label. Look for lot number KD4855 and expiration date 06/14.
Identify if your Risperidone Oral Solution has the lot number KD4855 and expiration date 06/14.
The recall states the product failed impurity testing at 18 months, but the official notice does not specify if it's safe to use after the expiration date.
The recall record does not provide specific action steps for affected users.
Check for the lot number KD4855 and expiration date 06/14 on the product label.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-1299-2014 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-1299-2014 from Apotex. 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.
