# FDA recall D-0403-2023

> **Accord Healthcare, Inc.** · Class II · drug recall initiated 2023-02-07.

## Product

Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial,  Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5

## Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

## Distribution

United States including Puerto Rico and Canada

## Key facts

- **Recall number:** D-0403-2023
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-07
- **Report date:** 2023-03-08
- **Termination date:** 2024-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0403-2023

## Citation

> AI Analytics. FDA recall D-0403-2023. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-0403-2023. Source: US FDA. Licensed CC0.

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