Drug Enforcement D-0656-2024

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
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Product quantity
1,732 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
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Codes & Dates

Recall number
D-0656-2024
Event ID
95190
Recall initiation date
August 22, 2024
Center classification date
September 5, 2024
Code info
Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024
More code info
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