The Recall Desk

FDA (Drugs) recall action 80383

Fagron Compounding Services LLC dba Fagron Sterile Services recalled 2 products on 2018-07-11

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
2018-07-11
Critical
0
Units
1,230

Why these products were recalled

Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.

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

  • SevereFDA (Drugs)··2018-07-11

    Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Fagron Sterile Services is recalling 840 prefilled syringes of Neostigmine Methylsulfate Injection Solution because they may be incorrectly labeled with the wrong strength.

    Product
    Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-07-11

    Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Fagron Compounding Services is recalling 390 prefilled syringes of Neostigmine Methylsulfate Injection Solution because some may be incorrectly labeled with the wrong strength.

    Product
    Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
    Category
    Distribution
    0 states