D-0655-2024 Class II Ongoing
FDA drug recall D-0655-2024 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: 1,489 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
- 1,489 vials
Product Description
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot # ProRx051424, BUD 11/13/2024