The Recall Desk

FDA (Drugs) recall action 72973

Pharmedium Services, LLC recalled 2 products on 2016-03-23

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
2016-03-23
Critical
0
Units
6,816

Why these products were recalled

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

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)··2016-03-23

    Pharmedium Recalls Subpotent Epinephrine Injection Bags

    Pharmedium Services, LLC is recalling 6,816 bags of subpotent epinephrine injection due to discoloration and FDA-confirmed potency issues.

    Product
    NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2016-03-23

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

    Pharmedium Services, LLC is recalling specific lots of repinephrine bitartrate injection bags due to subpotency and discoloration confirmed by FDA analysis.

    Product
    NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
    Category
    Distribution
    0 states