FDA-Drug2018-07-25Class II

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

La Vita Compounding Pharmacy, LLC
Hazard

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

Sold states
Product was distributed to patients via patient specific prescription only in CA.
Affected count
17,610 mL total dispensed in 10 mL and 30 mL vials
Manufactured in
3978 Sorrento Valley Blvd Ste 300, San Diego, CA, United States
Products
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

Official notice

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

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