Recalls / Class III
Class IIID-0913-2017
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Affected lot / code info
- Lot Numbers: 163640084D, 3/30/2017; 170120081D, 4/13/2017; 170160062D, 4/17/2017; 170200066D, 4/23/2017; 170370011D, 5/8/2017
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
- 216 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-0913-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.