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
Reason for recall: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: 20170626
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated