Hikma Injectables USA Inc. is recalling 1,895 bags of Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection because the packaging contains an incorrect barcode. The recall involves 100mL bags from lot CH0324001 with an expiration date of March 4, 2025. While the printed text on the label is correct, the barcode scan may provide wrong information, which could lead to medication errors in a hospital setting.
If a healthcare provider relies on scanning the barcode to identify or dispense the medication, the incorrect code could lead to a patient receiving the wrong drug or dosage. This poses a potential risk of a medication error, although no injuries or adverse events have been reported to date.
Hospital and clinical return of sterile injectables.
Compounded by Hikma Injectables USA Inc. in Cherry Hill, NJ.
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Sources: FDA iRES · Raw API Response
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