The Recall Desk

FDA (Drugs) recall action 73419

Apotex Scientific, Inc recalled 3 products on 2016-07-20

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
2016-07-20
Critical
0
Units
—

Why these products were recalled

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Drugs)··2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules, 60 mg, because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
    Category
    Distribution
    3 states
  • LowFDA (Drugs)··2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
    Category
    Distribution
    3 states
  • LowFDA (Drugs)··2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Failed Dissolution Testing

    Apotex Scientific is recalling specific lots of Duloxetine Delayed-Release Capsules because they failed dissolution specifications during stability testing.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
    Category
    Distribution
    3 states