TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Summary
The FDA issued a Class II for TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProR by ProRx LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0656-2024
Action Date
2024-09-11
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024
Quantity Affected: 1,732 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-22
Company
Exton, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
ProRx LLC has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ProRx LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ProRx LLC have FDA actions?
ProRx LLC has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0656-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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