The Recall Desk

FDA (Drugs) recall action 77634

PharMedium Services, Llc recalled 13 products on 2017-07-26

The FDA (Drugs) publishes a recall like this one as 13 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 13 pages.

Products
13
Announced
2017-07-26
Critical
0
Units
—

Why these products were recalled

Lack of Assurance of Sterility; media fill failure at manufacturer

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

1–13 of 13

  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMedium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMedium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection because a media fill failure at the manufacturer raised concerns about sterility.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that raises concerns about sterility.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMedium Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    PharMedium Services is recalling specific lots of Succinylcholine Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 S
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection because of a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2017-07-26

    PharMedium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMedium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure at the manufacturer that raises concerns about sterility.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Lan
    Category
    Distribution
    0 states