The Recall Desk

FDA (Drugs) recall action 74497

Teva North America recalled 4 products on 2016-09-14

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
2016-09-14
Critical
0
Units
121,663

Why these products were recalled

CGMP Deviations

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

  • ModerateFDA (Drugs)··2016-09-14

    Teva Recalls Argatroban Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 1,299 bags of Argatroban Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-09-14

    Teva Recalls Linezolid Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-09-14

    Teva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-09-14

    Teva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations

    Teva North America is recalling 13,223 vials of Ondansetron Injection USP due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
    Category
    Distribution
    1 state