Drug product
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
D-1255-2019
Product summary
- Event
- Event 82615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 vials
- Official record key
drug-enforcement:D-1255-2019
Official wording
Reason: Lack of assurance of sterility for injectables and solutions intended to be sterile.
Code information: Lot #: 02132019@25, Exp 5/14/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility