# FDA recall D-0656-2024

> **ProRx LLC** · Class II · drug recall initiated 2024-08-22.

## Product

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

Nationwide in the USA

## Key facts

- **Recall number:** D-0656-2024
- **Recalling firm:** ProRx LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-08-22
- **Report date:** 2024-09-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Exton, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0656-2024

## Citation

> AI Analytics. FDA recall D-0656-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0656-2024. Source: US FDA. Licensed CC0.

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