Drug product
GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy
D-0766-2017
Product summary
- Event
- Event 76912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 mL
- Official record key
drug-enforcement:D-0766-2017
Official wording
Reason: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Code information: Lot # t02-20-2017@75, Exp 4/22/2017.
Distribution pattern: Distributed nationwide in U.S.A., Australia and Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility