The Recall Desk

FDA (Drugs) recall action 87875

Teva Pharmaceuticals USA recalled 5 products on 2021-05-26

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2021-05-26
Critical
0
Units
10,170

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.

1–5 of 5

  • SevereFDA (Drugs)··2021-05-26

    Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling 3,150 vials of Haloperidol Decanoate Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-05-26

    Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Haloperidol Decanoate Injection because the company cannot guarantee the product is sterile.

    Product
    Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-05-26

    Teva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-05-26

    Teva Recalls Metoclopramide Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Metoclopramide Injection because there is a lack of assurance of sterility. The product was distributed nationwide.

    Product
    METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-05-26

    Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Leucovorin Calcium for Injection because the company cannot guarantee the product is sterile.

    Product
    Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 194
    Category
    Distribution
    0 states