The Recall Desk

FDA (Drugs) recall action 81730

Pharmedium Services, LLC recalled 2 products on 2018-12-26

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-12-26
Critical
0
Units
—

Why these products were recalled

Sub-potent

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

1–2 of 2

  • SevereFDA (Drugs)··2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Bags

    Pharmedium Services, LLC is voluntarily recalling 295 bags of Fentanyl Citrate and Ropivacaine HCl injection because the product was found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes

    Pharmedium Services, LLC is voluntarily recalling 295 syringes of a fentanyl and ropivacaine injection that were found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
    Category
    Distribution
    0 states