# FDA recall D-0806-2022

> **Olympia Compounding Pharmacy dba Olympia Pharmacy** · Class II · drug recall initiated 2022-04-04.

## Product

SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10.

## Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0806-2022
- **Recalling firm:** Olympia Compounding Pharmacy dba Olympia Pharmacy
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-04
- **Report date:** 2022-05-04
- **Termination date:** 2024-06-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0806-2022

## Citation

> AI Analytics. FDA recall D-0806-2022. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0806-2022. Source: US FDA. Licensed CC0.

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