The Recall Desk

FDA (Drugs) recall action 85756

Aurobindo Pharma USA Inc. recalled 2 products on 2020-06-24

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
2020-06-24
Critical
0
Units
20,869

Why these products were recalled

Failed Impurities/ Degradation Specifications

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

  • LowFDA (Drugs)··2020-06-24

    Aurobindo Recalls Olanzapine Tablets Due to Failed Impurity Specifications

    Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 7.5 mg, because the product failed impurity and degradation specifications.

    Product
    Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2020-06-24

    Aurobindo Pharma Recalls Olanzapine Tablets Due to Impurity Failures

    Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, because the product failed impurities and degradation specifications.

    Product
    Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
    Category
    Distribution
    0 states