PlainRecalls
FDA Drug Moderate Class II Terminated

TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Reported: May 8, 2019 Initiated: April 8, 2019 #D-1262-2019

Product Description

TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose 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.

Details

Units Affected
N/A
Distribution
U.S.A. Nationwide
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272. Recalled by Customceutical Compounding. Units affected: N/A.
Why was this product recalled?
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 8, 2019. Severity: Moderate. Recall number: D-1262-2019.