Drug product
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
D-1019-2013
Product summary
- Event
- Event 66084
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 vials
- Official record key
drug-enforcement:D-1019-2013
Official wording
Reason: Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Code information: Lot #: 20130715@12, Exp10/13/2013
Distribution pattern: Oregon and Washington
Derived failure modes
-
Microbial contamination
bacterial contamination
-
Potency or specification failure
Out Of Specification