The Recall Desk

FDA (Drugs) recall action 75300

Teva Pharmaceuticals USA recalled 3 products on 2016-10-26

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-10-26
Critical
0
Units
42,969

Why these products were recalled

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability 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.

States named across these recalls

1–3 of 3

  • LowFDA (Drugs)··2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling specific lots of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,556 bottles of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 32,015 bottles of Paricalcitol Capsules, 1 mcg, because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
    Category
    Distribution
    1 state