# FDA recall D-1091-2018

> **Ranier's Compounding Laboratory** · Class II · drug recall initiated 2018-07-25.

## Product

PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

## Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

## Distribution

Product was distributed within the state of Pennsylvania.

## Key facts

- **Recall number:** D-1091-2018
- **Recalling firm:** Ranier's Compounding Laboratory
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-25
- **Report date:** 2018-08-22
- **Termination date:** 2022-09-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1091-2018

## Citation

> AI Analytics. FDA recall D-1091-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1091-2018. Source: US FDA. Licensed CC0.

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