Drug 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
D-1261-2019
Product summary
- Event
- Event 82615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 vials
- Official record key
drug-enforcement:D-1261-2019
Official wording
Reason: Lack of assurance of sterility for injectables and solutions intended to be sterile.
Code information: Lot #: 02182019@27, Exp 8/02/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility