FDA Drug Recalls

Recalls / Class II

Class IID-0172-2019

Product

Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20

Affected lot / code info
Lot: 06252018:63 Discard by: 12/22/2018; 07312018:35 Discard by: 1/26/2019

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
1900 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-0172-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.