The Recall Desk

FDA (Drugs) recall action 80638

PharMEDium Services, LLC recalled 3 products on 2018-08-15

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2018-08-15
Critical
0
Units
1,255

Why these products were recalled

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

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.

1–3 of 3

  • ModerateFDA (Drugs)··2018-08-15

    PharMEDium Recalls Fentanyl Citrate IV Bags Due to CGMP Deviations

    PharMEDium Services is recalling specific lots of Fentanyl Citrate IV bags because they were released while a hood certification discrepancy was under investigation.

    Product
    10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-08-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to CGMP Deviations

    PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide because the product was released while a hood certification discrepancy was under investigation.

    Product
    10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-08-15

    PharMEDium Recalls Ephedrine Sulfate Syringes Due to CGMP Deviations

    PharMEDium Services is recalling 450 syringes of Ephedrine Sulfate because the product was released while a hood certification discrepancy was under investigation.

    Product
    5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
    Category
    Distribution
    0 states