# FDA recall D-0529-2023

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2023-03-29.

## Product

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.

## Reason for recall

Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0529-2023
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-03-29
- **Report date:** 2023-04-19
- **Termination date:** 2023-10-31

- **Voluntary/Mandated:** N/A
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0529-2023

## Citation

> AI Analytics. FDA recall D-0529-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0529-2023. Source: US FDA. Licensed CC0.

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