Recalls / Class II
Class IID-0908-2017
Product
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Affected lot / code info
- Lot Numbers: 170020074D, 4/3/2017; 170050071D, 4/6/2017; 170270036D, 4/30/2017
Why it was recalled
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 144 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-02-17
- FDA classified
- 2017-06-12
- Posted by FDA
- 2017-06-21
- Terminated
- 2017-06-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0908-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.