Drug Enforcement D-0650-2024

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

September 11, 2024

Termination Date

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Product Information

Product description
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
Product quantity
2,490 vials
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
ProRx LLC
Address
619 Jeffers Cir

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

Codes & Dates

Recall number
D-0650-2024
Event ID
95190
Recall initiation date
August 22, 2024
Center classification date
September 5, 2024
Code info
Lot #: ProRx031924, BUD 09/18/2024 ProRx032624, BUD 09/25/2024 ProRx041324, BUD 10/12/2024
More code info
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