Drug product

Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02

D-0200-2019

September 10, 2018

Class II

Product summary

Firm: Pharm D Solutions, LLC
Event: Event 81002
Status: Terminated
Classification: Class II
Quantity: 815 vials
Official record key: drug-enforcement:D-0200-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 03292018:70 Discard by: 9/25/2018; 05302018:94 Discard by: 11/26/2018; 06072018:67 Discard by: 12/4/2018; 06122018:72 Discard by: 12/9/2018; 07252018:72 Discard by: 1/21/2019

Distribution pattern: Nationwide

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility