FDA recall D-1431-2015

The Compounding Pharmacy of America · Class II · drug

Product

5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-06-02
Report date
2015-09-23
Termination date
2016-02-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Knoxville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1431-2015