FDA-Drug2018-07-25Class II

Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, 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
191 vials
Manufactured in
3978 Sorrento Valley Blvd Ste 300, San Diego, CA, United States
Products
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0923-2018

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