# FDA recall D-0174-2017

> **Fallon Wellness Pharmacy, L.L.C.** · Class II · drug recall initiated 2016-11-02.

## Product

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL  Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY  12110.

## Reason for recall

Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.

## Distribution

NY

## Key facts

- **Recall number:** D-0174-2017
- **Recalling firm:** Fallon Wellness Pharmacy, L.L.C.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-02
- **Report date:** 2016-12-14
- **Termination date:** 2018-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Latham, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2017

## Citation

> AI Analytics. FDA recall D-0174-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0174-2017. Source: US FDA. Licensed CC0.

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