FDA recall D-0922-2018

Product

Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

Reason for recall

Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.

Distribution

Product was distributed to patients via patient specific prescription only in CA.

Key facts

Status

Terminated

Initiation date

2018-06-25

Report date

2018-07-25

Termination date

2019-01-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0922-2018