Drug product
Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
D-1339-2019
Product summary
- Event
- Event 82941
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 vials
- Official record key
drug-enforcement:D-1339-2019
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 05022019:90 Exp. 07/13/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility