FDA Drug Recalls

Recalls / Class II

Class IID-0204-2019

Product

Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05

Affected lot / code info
Lot: 04262018:54 Discard by: 10/23/2018; 03292018:91 Discard by: 9/24/2018; 05312018:10 Discard by: 11/27/2018

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
59 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-0204-2019. 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