# FDA recall D-1143-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2022-05-06.

## Product

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy,  NDC 50102-591-40.

## Reason for recall

Lack of assurance of sterility

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-1143-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-06
- **Report date:** 2022-06-22
- **Termination date:** 2023-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1143-2022

## Citation

> AI Analytics. FDA recall D-1143-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1143-2022. Source: US FDA. Licensed CC0.

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