Akorn recalls 500mL Oxycodone Hydrochloride Oral Solution bottles due to missing labels. This could lead to incorrect dosing if used without proper labeling.
Labeling: Missing Label
Akorn is recalling 500mL bottles of Oxycodone Hydrochloride Oral Solution (5 mg per 5 mL) because the labels are missing. This means users might not know the correct dosage, which could lead to unsafe medication use.
The missing label means the product lacks critical information like dosage instructions and expiration dates. Without this, users might not know how much medication to take, potentially leading to unsafe dosing.
Prescription holders who have the 500mL bottle of Oxycodone Hydrochloride Oral Solution with the specified lot numbers and expiration dates are affected. Healthcare providers and patients using this medication are at risk of incorrect dosing.
Check for the 500mL bottle labeled 'Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL)'. Look for lot numbers 377186 (expiring 2/28/2023) or 377188 (expiring 3/31/2023).
Verify if the label is missing or damaged on the bottle.
No, the missing label means you cannot safely use this product without knowing the correct dosage.
The recall does not specify a remedy, so contact Akorn for guidance on safe disposal or alternatives.
Look for the 500mL bottle with lot numbers 377186 (expiring 2/28/2023) or 377188 (expiring 3/31/2023).
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0368-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0368-2022 from Akorn. 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.
