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
Product summary
- 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
Lack of Processing Controls