# FDA recall D-0778-2023

> **New England Life Care, Inc. dba Advanced Compounding Solutions** · Class III · drug recall initiated 2023-05-22.

## Product

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25

## Reason for recall

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0778-2023
- **Recalling firm:** New England Life Care, Inc. dba Advanced Compounding Solutions
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-22
- **Report date:** 2023-06-07
- **Termination date:** 2023-07-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woburn, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0778-2023

## Citation

> AI Analytics. FDA recall D-0778-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0778-2023. Source: US FDA. Licensed CC0.

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