D-0990-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 26, 2017
- Initiation Date
- June 26, 2017
- Termination Date
- April 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
Reason for Recall
Lack of Assurance of Sterility; media fill failure at manufacturer
Distribution Pattern
Nationwide
Code Information
Lots: 171220007S Exp. 7/31/2017, 171280129S Exp. 8/7/2017, 171320112S Exp. 8/13/2017, 171590010S Exp. 9/7/2017