Recalls / Class III

Class IIID-0911-2017

Product

Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Affected lot / code info

Lot Numbers: 163640076D, 3/30/2017; 170040009D, 4/5/2017; 170040224S, 4/5/2017; 170040065S, 4/5/2017; 170050068D, 4/6/2017; 170060353S, 4/9/2017; 170100076D, 4/11/2017; 170100111S, 4/11/2017; 170120090D, 4/13/2017; 170120154S, 4/13/2017; 170160150S, 4/17/2017; 170260005D, 4/27/2017; 170380110S, 5/9/2017; 170400085S, 5/11/2017

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

672 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-0911-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.