FDA (Drugs) recall action 77191

Pharmedium Services, LLC recalled 11 products on 2017-06-21

The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2017-06-21
Critical: 0
Units: 3,527

Why these products were recalled

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

ModerateFDA (Drugs)··2017-06-21
Pharmedium Recalls Vancomycin Bags With Incorrect Volume Labeling
Pharmedium Services is recalling 816 bags of Vancomycin HCl injection because the total volume was incorrectly labeled as 500 mL instead of 300 mL.
Product
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Distribution
0 states
ModerateFDA (Drugs)··2017-06-21
Pharmedium Recalls Vancomycin Injection Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 108 bags of Vancomycin HCl injection because the total volume was incorrectly printed on the label.
Product
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Distribution
0 states
LowFDA (Drugs)··2017-06-21
Pharmedium Recalls Potassium Phosphate IV Bags Due to Labeling Error
Pharmedium Services is recalling 48 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Distribution
0 states
LowFDA (Drugs)··2017-06-21
Pharmedium Recalls Potassium Phosphate IV Bags Due to Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 672 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
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
Category
Distribution
0 states
ModerateFDA (Drugs)··2017-06-21
Pharmedium Recalls Potassium Phosphate Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 144 bags of Potassium Phosphate in 0.5% Dextrose because the product label incorrectly states a volume of 150 mL instead of the actual 100 mL.
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
Category
Distribution
0 states
LowFDA (Drugs)··2017-06-21
Pharmedium Recalls Potassium Chloride Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 143 bags of Potassium Chloride in 0.9% Sodium Chloride because the product label incorrectly states the total volume as 105.00 mL instead of 100.00 mL.
Product
Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Category
Distribution
0 states
LowFDA (Drugs)··2017-06-21
Pharmedium Recalls IV Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 192 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Distribution
0 states
LowFDA (Drugs)··2017-06-21
Pharmedium Recalls IV Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 912 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
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
Category
Distribution
0 states
LowFDA (Drugs)··2017-06-21
Pharmedium Recalls IV Bags with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Phosphate in 0.9% Sodium Chloride because the total volume was incorrectly printed on the label.
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
Category
Distribution
0 states
ModerateFDA (Drugs)··2017-06-21
Pharmedium Recalls Vancomycin Injection Bags With Incorrect Volume Labeling
Pharmedium Services is recalling 60 bags of Vancomycin HCl injection because the label incorrectly states 500 mL instead of the actual 300 mL volume.
Product
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Category
Distribution
0 states
LowFDA (Drugs)··2017-06-21
Pharmedium Recalls 216 Bags of Potassium Chloride with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride in 0.9% Sodium Chloride because the product labels incorrectly state a volume of 115.00 mL instead of the actual 100.00 mL.
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
Category
Distribution
0 states