Drug product

Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1369-02

D-0202-2019

September 10, 2018

Class II

Product summary

Firm: Pharm D Solutions, LLC
Event: Event 81002
Status: Terminated
Classification: Class II
Quantity: 195 vials
Official record key: drug-enforcement:D-0202-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 05302018:59 Discard by: 11/26/2018; 06132018:44 Discard by: 12/10/2018; 06062018:64 Discard by: 12/3/2018; 07262018:97 Discard by: 11/1/2018; 07052018:23 Discard by: 1/1/2019

Distribution pattern: Nationwide

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility