A Class II recall of 37 compounded multidose vials, initiated in August 2024 and classified that September, carries the status ongoing in the enforcement file.
Silver Spring, Maryland, 11 September 2024 — The Food and Drug Administration enforcement file records a Class II recall initiated by ProRx LLC of Exton, Pennsylvania, on 22 August 2024 and classified on 5 September 2024. The record covers 37 multidose vials of a compounded tirzepatide injection distributed nationwide, gives the reason as lack of assurance of sterility, and still carries the status ongoing.
Source documents
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Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
- Identifier
- Recall number D-0651-2024
- As the record states
- Lack of Assurance of Sterility
- Recalling firm
- ProRx LLC
- Firm location
- Exton, PA, United States
- Classification
- Class II
- Status on the record
- Ongoing
- Quantity
- 37 vials
- Distribution
- Nationwide in the USA
- Initiated
- 2024-08-22
- Classified
- 2024-09-05