Drug product

Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02

D-0201-2019

September 10, 2018

Class II

Product summary

Firm: Pharm D Solutions, LLC
Event: Event 81002
Status: Terminated
Classification: Class II
Quantity: 430 vials
Official record key: drug-enforcement:D-0201-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 06132018:87 Discard by: 12/10/2018; 05302018:66 Discard by: 11/25/2018; 06122018:54 Discard by: 11/17/2018; 07252018:88 Discard by: 1/21/2019

Distribution pattern: Nationwide

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility