D-1261-2019 Class II Terminated
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