FDA Drug Recalls

Recalls / Class II

Class IID-0206-2019

Product

Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03

Affected lot / code info
Lot: 04102018:12 Discard by: 10/7/2018; 05102018:06 Discard by: 11/6/2018; 05222018:76 Discard by: 11/18/2018; 07022018:35 Discard by: 12/29/2018; 08272018:00 Discard by: 1/14/2019; 08082018:14 Discard by: 2/4/2019

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Pharm D Solutions, LLC
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
1304 S Loop W, N/A, Houston, Texas 77054-4010

Distribution

Quantity
336 milliliters
Distribution pattern
Nationwide

Timeline

Recall initiated
2018-09-10
FDA classified
2018-11-01
Posted by FDA
2018-11-07
Terminated
2021-02-05
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0206-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls