The Recall Desk

FDA (Drugs) recall action 71844

Pharmedium Services, LLC recalled 8 products on 2015-09-30

The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.

Products
8
Announced
2015-09-30
Critical
1
Units
1,299

Why these products were recalled

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

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.

1–8 of 8

  • SevereFDA (Drugs)··2015-09-30

    Pharmedium Recalls Phenylephrine Injection Due to Human Hair Particulate Matter

    Pharmedium Services is recalling 84 bags of Phenylephrine HCl injection because the sodium chloride base contained human hair.

    Product
    PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-30

    Pharmedium Recalls Phenylephrine Injection Bags Due to Particulate Matter

    Pharmedium Services is recalling 120 bags of Phenylephrine HCl injection due to the presence of human hair particulate matter.

    Product
    PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-30

    PharMEDium Recalls Morphine Sulfate IV Bags Due to Particulate Matter

    PharMEDium Services is recalling 100 bags of Morphine Sulfate IV solution because the sodium chloride used contained human hair.

    Product
    Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-30

    Pharmedium Recalls Phenylephrine Injection Due to Human Hair Contamination

    Pharmedium Services, LLC is recalling specific lots of Phenylephrine HCl injection because the sodium chloride base used contained human hair.

    Product
    PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-30

    Pharmedium Phenylephrine Injection Recalled for Particulate Matter

    Pharmedium Services, LLC is recalling 48 bags of Phenylephrine HCl injection due to the presence of particulate matter, specifically human hair, in the product.

    Product
    PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-30

    Pharmedium Recalls Phenylephrine Injection Due to Human Hair Particulate Matter

    Pharmedium Services is recalling specific lots of Phenylephrine HCl injection due to the presence of human hair particulate matter.

    Product
    PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2015-09-30

    PharMEDium Recalls Bupivacaine Bags Due to Human Hair Particulate Matter

    PharMEDium Services is recalling 20 bags of Bupivacaine HCl 0.0625% for epidural use because they contain human hair particulate matter.

    Product
    Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-30

    PharMEDium Recalls Fentanyl Citrate IV Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 663 bags of Fentanyl Citrate IV solution because the sodium chloride used contained human hair.

    Product
    Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50
    Category
    Distribution
    0 states