# FDA recall D-0421-2024

> **SCA Pharmaceuticals, LLC** · Class II · drug recall initiated 2023-11-09.

## Product

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0421-2024
- **Recalling firm:** SCA Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-11-09
- **Report date:** 2024-04-03
- **Termination date:** 2024-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Windsor, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0421-2024

## Citation

> AI Analytics. FDA recall D-0421-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0421-2024. Source: US FDA. Licensed CC0.

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