# FDA recall D-0669-2023

> **Central Admixture Pharmacy Services, Inc.** · Class II · drug recall initiated 2023-04-28.

## Product

Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-0203-1.

## Reason for recall

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0669-2023
- **Recalling firm:** Central Admixture Pharmacy Services, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-04-28
- **Report date:** 2023-05-31
- **Termination date:** 2025-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0669-2023

## Citation

> AI Analytics. FDA recall D-0669-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0669-2023. Source: US FDA. Licensed CC0.

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