FDA Drug Recalls

Recalls / Class II

Class IID-0153-2019

Product

Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59

Affected lot / code info
Lots: 01402018:93 Discard by: 10/10/2018; 07122018:16 Discard by: 9/10/2018; 08302018:65 Discard by:

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
1095 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-0153-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.