D-1261-2019 Class II Terminated

Recalled by Customceutical Compounding — Phoenix, AZ

Recall Details

Product Type
Drugs
Report Date
May 8, 2019
Initiation Date
April 8, 2019
Termination Date
May 19, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 vials

Product Description

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 Pattern

U.S.A. Nationwide

Code Information

Lot #: 02182019@27, Exp 8/02/19