Recalls / Class II
Class IID-0993-2017
Product
Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48
- Affected lot / code info
- Lot: 171450017D, 8/24/2017
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-0993-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.