PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 25, 2018 Initiated: June 25, 2018 #D-0923-2018

Product Description

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

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.

Details

Units Affected
191 vials
Distribution
Product was distributed to patients via patient specific prescription only in CA.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by La Vita Compounding Pharmacy, LLC. Units affected: 191 vials.
Why was this product recalled? ▼
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 25, 2018. Severity: Moderate. Recall number: D-0923-2018.

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