Drug product
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
D-0638-2018
Product summary
- Event
- Event 79619
- Status
- Terminated
- Classification
- Class II
- Quantity
- four vials
- Official record key
drug-enforcement:D-0638-2018
Official wording
Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Code information: Lot#: 20180219@58, BUD 05/20/2018; 20180131@15, BUD 05/01/2018; 20180116@9, BUD 04/14/2018; 20180103@5, BUD 04/03/2018.
Distribution pattern: NV only
Derived failure modes
-
Unknown
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.