The Recall Desk

FDA (Drugs) recall action 81457

Sandoz Inc recalled 6 products on 2018-11-21

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2018-11-21
Critical
0
Units
70,718

Why these products were recalled

Cross Contamination with Other Products

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.

1–6 of 6

  • SevereFDA (Drugs)··2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 5,100 bottles of Isosorbide Dinitrate Tablets, USP 10 mg, due to cross contamination with other products.

    Product
    Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling Isosorbide Dinitrate Tablets 5 mg due to cross-contamination with other products. The recall affects 7,817 bottles distributed nationwide.

    Product
    Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-11-21

    Sandoz Recalls Nitrofurantoin Capsules Due to Cross Contamination

    Sandoz Inc is recalling specific lots of Nitrofurantoin capsules because they may be cross-contaminated with other products.

    Product
    NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS))
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 1,550 bottles of Isosorbide Dinitrate Tablets 20 mg due to cross-contamination with other products.

    Product
    Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2018-11-21

    Sandoz Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    Sandoz Inc. is recalling specific lots of Nitrofurantoin Capsules 100 mg due to cross-contamination with other products.

    Product
    Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
    Category
    Distribution
    0 states