FDA recall D-1261-2019

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

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

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