D-0923-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2018
- Initiation Date
- June 25, 2018
- Termination Date
- January 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191 vials
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.
Distribution Pattern
Product was distributed to patients via patient specific prescription only in CA.
Code Information
Lot #: 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018