The Recall Desk

FDA (Drugs) recall action 74068

Sandoz, Inc recalled 2 products on 2016-06-29

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
2016-06-29
Critical
0
Units
78,606

Why these products were recalled

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

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.

1–2 of 2

  • ModerateFDA (Drugs)··2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Test Failure

    Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.

    Product
    Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Testing Failures

    Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules because testing revealed out-of-specification results for a known impurity.

    Product
    Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
    Category
    Distribution
    0 states