Drug product

Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05

D-0175-2019

September 10, 2018

Class II

Product summary

Firm: Pharm D Solutions, LLC
Event: Event 81002
Status: Terminated
Classification: Class II
Quantity: 189 milliliters
Official record key: drug-enforcement:D-0175-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 04252018:84 Discard by: 10/22/2018; 03292018:62 Discard by: 9/24/2018; 05312018:52 Discard by: 11/27/2018; 07022018:82 Discard by: 11/17/2018; 06122018:96 Discard by: 12/9/2018; 07242018:22 Discard by: 1/20/2019; 08302018:71 Discard by: 2/23/2019

Distribution pattern: Nationwide

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility