The Recall Desk

FDA (Drugs) recall action 68191

Pharmakon Pharmaceuticals recalled 4 products on 2014-09-03

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2014-09-03
Critical
2
Units
225

Why these products were recalled

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

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.

States named across these recalls

1–4 of 4

  • CriticalFDA (Drugs)··2014-09-03

    Pharmakon Recalls Midazolam HCl Vials Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl 2 mg/ml vials because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
    Category
    Distribution
    4 states
  • SevereFDA (Drugs)··2014-09-03

    Pharmakon Recalls Glycopyrrolate Syringes for Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling 200 pre-filled syringes of Glycopyrrolate 0.2 mg/ml because they contain undeclared benzyl alcohol.

    Product
    Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
    Category
    Distribution
    4 states
  • SevereFDA (Drugs)··2014-09-03

    Pharmakon Recalls Midazolam IV Bags Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl IV bags because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715.
    Category
    Distribution
    4 states
  • CriticalFDA (Drugs)··2014-09-03

    Pharmakon Recalls Atropine Sulfate Syringes Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Atropine Sulfate Injection because they contain undeclared benzyl alcohol.

    Product
    Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
    Category
    Distribution
    4 states