The Recall Desk

FDA (Drugs) recall action 88442

Teva Pharmaceuticals USA recalled 19 products on 2021-08-25

The FDA (Drugs) publishes a recall like this one as 19 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 19 pages.

Products
19
Announced
2021-08-25
Critical
0
Units
1,409,440

Why these products were recalled

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.

States named across these recalls

1–19 of 19

  • HighFDA (Drugs)··2021-08-25

    Adenosine Injection Vials Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.

    Product
    Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.

    Product
    Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Methylprednisolone Acetate Injectable Suspension recalled for sterility concerns

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Idarubicin Hydrochloride Injection Recalled Due to Sterility Concerns

    Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.

    Product
    Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Teva Octreotide Acetate Injection Recall: Sterility Assurance Loss

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.

    Product
    Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Octreotide Acetate Injection 50 mcg/mL Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 50 mcg/mL in single-dose vials due to lack of assurance of sterility. The recall affects specific lots distributed nationwide, including Puerto Rico.

    Product
    Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.

    Product
    METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Teva Vecuronium Bromide Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.

    Product
    Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Amikacin Sulfate Injection Recalled Due to Sterility Assurance Failure

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.

    Product
    Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Leucovorin Calcium Injection Recalled Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.

    Product
    Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance

    Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Teva Epoprostenol Sodium for Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    DAUNOrubicin Hydrochloride Injection Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.

    Product
    DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Haloperidol Decanoate Injection recalled due to sterility concerns

    Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.

    Product
    Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Leucovorin Calcium for Injection recalled for lack of sterility assurance

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.

    Product
    Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Leucovorin Calcium for Injection Recalled Due to Sterility Assurance Concerns

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.

    Product
    Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Adenosine Injection Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.

    Product
    Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-08-25

    Teva Alprostadil Injection Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.

    Product
    Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
    Category
    Distribution
    1 state