The Recall Desk

FDA (Drugs) recall action 76912

Key Pharmacy and Compounding Center recalled 79 products on 2017-05-24

The FDA (Drugs) publishes a recall like this one as 79 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 79 pages.

Products
79
Announced
2017-05-24
Critical
0
Units
1,162

Why these products were recalled

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

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.

76–79 of 79

  • SevereFDA (Drugs)··2017-05-24

    Key Pharmacy Recalls DMSO 6.25% Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling DMSO 6.25% Ophthalmic Solution because the firm cannot ensure the product is sterile.

    Product
    DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.

    Product
    HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-05-24

    Key Pharmacy Recalls Sterile Compounded Drug Vials Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 17 vials of TRI MIX 20/30/2 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial , Prepared by Key Compounding Pharmacy
    Category
    Distribution
    0 states