Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0923-2018

June 25, 2018

Class II

Product summary

Firm
La Vita Compounding Pharmacy, LLC
Event
Event 80416
Status
Terminated
Classification
Class II
Quantity
191 vials
Official record key
drug-enforcement:D-0923-2018

Official wording

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

Code information: Lot #: 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls