Recalls / Class II
Class IID-0996-2017
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
- Affected lot / code info
- Lots: a) 171180027S Exp. 7/29/2017, 171220058D Exp. 8/1/2017, 171230013S Exp. 8/2/2017, 171360008S Exp. 8/14/2017, 171360019D Exp. 8/15/2017, 171380085D Exp. 8/17/2017, 171430069D Exp. 8/22/2017, 171560025D Exp. 9/4/2017; b) 171240007S Exp. 8/3/2017, 171280055D Exp. 8/7/2017, 171320003D Exp. 8/10/2017, 171320008S Exp. 8/13/2017, 171360005S Exp. 8/14/2017, 171370011S Exp. 8/16/2017, 171380086D Exp. 8/17/2017, 171500071D Exp. 8/29/2017
Why it was recalled
Lack of Assurance of Sterility; media fill failure at manufacturer
Recalling firm
- Firm
- PharMedium Services, Llc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 12620 W Airport Blvd Ste 130, N/A, Sugar Land, Texas 77478-6200
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-06-26
- FDA classified
- 2017-07-14
- Posted by FDA
- 2017-07-26
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0996-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.