Drug product
STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 10 ML vial: 70731-0188-10; NDC 30 ML vial: 70731-0188-30; NDC 50 ML vial: 70731-0188-50
D-1707-2019
Product summary
- Event
- Event 83074
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1707-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry
Distribution pattern: Nationwide USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility