The Recall Desk

FDA (Drugs) recall action 74816

Teva Pharmaceuticals USA recalled 2 products on 2016-10-19

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-10-19
Critical
0
Units
39,391

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

1–2 of 2

  • SevereFDA (Drugs)··2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 27,547 vials of Amikacin Sulfate Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
    Category
    Distribution
    1 state