Drug Enforcement D-0480-2024

Labeling: Wrong Barcode

Status

Completed

Classification

Class III

Report Date

May 8, 2024

Termination Date

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Product Information

Product description
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Product quantity
1,895 bags
Reason for recall
Labeling: Wrong Barcode
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Hikma Injectables USA Inc
Address
36 Stults Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0480-2024
Event ID
94528
Recall initiation date
April 30, 2024
Center classification date
May 2, 2024
Code info
Lot #: CH0324001, Exp. Date 3/4/2025
More code info
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