Drug Enforcement D-0432-2024

Lack of Assurance of Sterility: leaking bags

Status

Ongoing

Classification

Class II

Report Date

April 10, 2024

Termination Date

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Product Information

Product description
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Product quantity
187 cassettes
Reason for recall
Lack of Assurance of Sterility: leaking bags
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the U.S

Location & Firm

Recalling firm
IntegraDose Compounding Services LLC
Address
719 Kasota Ave Se

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0432-2024
Event ID
94275
Recall initiation date
March 22, 2024
Center classification date
April 3, 2024
Code info
Lot#: 20231020FEN-1, Exp: 04/17/2024
More code info
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