Drug product
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
D-1121-2015
Product summary
- Event
- Event 71275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20/4 mL vials
- Official record key
drug-enforcement:D-1121-2015
Official wording
Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Code information: Lot 04102015:70@12; expiry date 5/28/2015.
Distribution pattern: MT and ND
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility