Recalls / Class III

Class IIID-0910-2017

Product

Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Affected lot / code info

Lot Numbers: 170050001D, 4/5/2017; 170040025D, 4/5/2017; 170060046D, 4/9/2017; 170090062D, 4/10/2017; 170110125S, 4/12/2017; 170170016S, 4/18/2017; 170200120S, 4/23/2017; 170380108S, 5/9/2017;

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

912 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-0910-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.