Akorn recalls 30mL Morphine Sulfate Oral Solution bottles (Rx only) due to missing labels. This could lead to incorrect dosing if used without proper labeling.
Labeling: Missing Label
Akorn is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL bottles because they lack labels. This means patients might not get the correct dose if they use the product without proper labeling.
The missing label means the product lacks critical information about dosage, which could lead to incorrect dosing if used without proper labeling. This is a labeling issue that affects safe medication use.
Prescription patients who have the 30mL Morphine Sulfate Oral Solution bottles with the specific NDC number and lot code. Those who use the product without proper labeling are at risk of incorrect dosing.
Check for 30mL bottles labeled 'Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL)' with NDC 50383-965-30 and lot number 375153. These were sold by Hi-Tech Pharmacal Co., Inc. in Amityville, NY.
Look for the missing label on the bottle to confirm if it's part of the recall.
The product is safe if it has a label. Without a label, it could lead to incorrect dosing, so check the label first.
The recall does not specify a remedy, so check the label to see if it's missing. If it is, contact your pharmacist for guidance.
Look for the NDC number 50383-965-30 and lot number 375153 on the bottle. These were sold by Hi-Tech Pharmacal Co., Inc. in Amityville, NY.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0367-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0367-2022 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.
