# FDA recall D-1153-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2022-06-03.

## Product

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

## Reason for recall

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-1153-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-03
- **Report date:** 2022-06-29
- **Termination date:** 2023-05-24

- **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-1153-2022

## Citation

> AI Analytics. FDA recall D-1153-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1153-2022. Source: US FDA. Licensed CC0.

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