The Recall Desk

FDA (Drugs) recall action 77856

PharMedium Services, Llc recalled 2 products on 2017-09-27

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
2017-09-27
Critical
0
Units
885

Why these products were recalled

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

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.

1–2 of 2

  • ModerateFDA (Drugs)··2017-09-27

    PharMEDium Recalls Fentanyl Citrate Due to Expired Diluent

    PharMEDium Services is recalling 295 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-09-27

    PharMEDium Recalls Fentanyl Citrate Bags Due to Expired Diluent

    PharMEDium Services is recalling 590 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
    Category
    Distribution
    0 states