The Recall Desk

FDA (Drugs) recall action 71846

Pharmedium Services, LLC recalled 6 products on 2015-09-02

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2015-09-02
Critical
4
Units
1,140

Why these products were recalled

Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

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.

1–6 of 6

  • CriticalFDA (Drugs)··2015-09-02

    PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 240 bags of Heparin Sodium Injection USP 25,000 Units in 250 mL bags due to the presence of particulate matter.

    Product
    HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2015-09-02

    PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 48 bags of Epinephrine HCl injection due to the presence of particulate matter in the solution.

    Product
    EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2015-09-02

    PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 264 bags of Epinephrine HCl injection due to the presence of particulate matter in the saline solution.

    Product
    EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-02

    PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter

    PharMEDium Services is recalling 480 bags of Heparin Sodium Injection USP due to the presence of particulate matter. The product was distributed nationwide.

    Product
    HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-02

    Pharmedium Recalls Oxytocin Injection Bags Due to Particulate Matter

    Pharmedium Services, LLC is recalling 72 bags of oxyTOCIN 15 Units in 5% Dextrose Injection due to the presence of particulate matter.

    Product
    oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2015-09-02

    PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter

    PharMEDium Services is recalling 36 bags of Epinephrine HCl injection due to the presence of particulate matter in the solution.

    Product
    EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61.
    Category
    Distribution
    0 states