Hikma Injectables USA recalls fentanyl 1000mcg/100mL injections with wrong barcode labeling. This affects compounded products sold in 100mL bags. Contact for remedy details.
Labeling: Wrong Barcode
Hikma Injectables USA recalled fentanyl injections that have incorrect barcodes. This labeling error could lead to confusion in identifying the product, which is critical for safe medical use.
The product has a wrong barcode label, which could cause misidentification. This is a labeling error that might lead to confusion about the product's identity, but does not pose an immediate safety risk during normal use.
Prescribers and patients using this specific fentanyl injection product for medical purposes. Those who have the product with the listed lot number are most at risk.
Check for the product name 'Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection' in 100mL bags. Look for the lot number CH0324001 and expiration date 3/4/2025 on the packaging.
Verify the lot number and expiration date on the packaging to confirm if it matches CH0324001 expiring 3/4/2025.
The product is safe for use if the barcode label is correct. However, this recall is due to a wrong barcode, so it's recommended to check the label before use.
Check the product label for the lot number CH0324001 and expiration date 3/4/2025. If it matches, contact Hikma Injectables USA for further instructions.
The recall record does not specify a replacement process. Contact Hikma Injectables USA directly for assistance.
We’ve drafted a message you can send Hikma Injectables to request your refund or repair — edit it as you like.
Subject: Recall D-0480-2024 — Hikma Injectables Hikma Injectables Hello, I own a Hikma Injectables that is covered by recall D-0480-2024 from Hikma Injectables. 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.
