Recalls / Class III

Class IIID-0906-2017

Product

Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

Affected lot / code info

Lot Numbers: 70090135M, 2/27/2017; 170250101M, 3/15/2017; 170030011D, 4/4/2017; 170040078D, 4/5/2017; 170310012D, 5/2/2017; 170400046D, 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

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-0906-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.