D-0656-2024 Class II Ongoing
FDA drug recall D-0656-2024 was initiated by ProRx LLC on August 22, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 1,732 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 11, 2024
- Initiation Date
- August 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,732 vials
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024