# FDA recall D-0801-2018

> **Coast Quality Pharmacy LLC** · Class II · drug recall initiated 2018-04-26.

## Product

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

## Reason for recall

Lack of Assurance of Sterility

## Distribution

AL, CA, FL, MI, SC, TX

## Key facts

- **Recall number:** D-0801-2018
- **Recalling firm:** Coast Quality Pharmacy LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-26
- **Report date:** 2018-05-16
- **Termination date:** 2020-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0801-2018

## Citation

> AI Analytics. FDA recall D-0801-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0801-2018. Source: US FDA. Licensed CC0.

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