Drug product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
D-0986-2017
Product summary
- Event
- Event 77634
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0986-2017
Official wording
Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Code information: Lots: a) 171280006S Exp. 8/6/2017; 171280125S Exp. 8/7/2017; 171290006S Exp. 8/7/2017; 171290028D Exp. 8/8/2017; 171360002S Exp. 8/15/2017; b) 171280011S Exp. 8/7/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility