The Recall Desk

FDA (Drugs) recall action 76951

Isomeric Pharmacy Solution, LLC recalled 7 products on 2017-05-03

The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2017-05-03
Critical
0
Units
18,811

Why these products were recalled

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

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

1–7 of 7

  • HighFDA (Drugs)··2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 1,951 vials of Triamcinolone Diacetate injection because production processes cannot assure sterility. The FDA has classified this as a Class II recall.

    Product
    Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-05-03

    Isomeric Pharmacy Recalls Testosterone Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,156 vials of Testosterone Cypionate and Propionate injection due to production processes that cannot assure sterility.

    Product
    Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Acetonide Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,335 vials of Triamcinolone Acetonide and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-05-03

    Isomeric Pharmacy Recalls Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 851 vials of a multi-dose injection product because production processes cannot assure sterility.

    Product
    Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-05-03

    Isomeric Pharmacy Recalls Phenylephrine and Tropicamide Ophthalmic Drops

    Isomeric Pharmacy Solution, LLC is recalling 5,165 bottles of Phenylephrine 2.5% and Tropicamide 1% ophthalmic drops due to a lack of assurance of sterility.

    Product
    Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 4,001 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,352 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
    Category
    Distribution
    1 state