# FDA recall D-1261-2019

> **Customceutical Compounding** · Class II · drug recall initiated 2019-04-08.

## Product

Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

## Reason for recall

Lack of assurance of sterility for injectables and solutions intended to be sterile.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1261-2019
- **Recalling firm:** Customceutical Compounding
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-08
- **Report date:** 2019-05-08
- **Termination date:** 2023-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Phoenix, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1261-2019

## Citation

> AI Analytics. FDA recall D-1261-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1261-2019. Source: US FDA. Licensed CC0.

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