Drug product
Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
D-0995-2017
Product summary
- Event
- Event 77634
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0995-2017
Official wording
Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Code information: Lots: 171160002S Exp. 7/26/2017, 171560007S Exp. 9/4/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility