The Recall Desk

FDA (Drugs) recall action 75565

Teva Pharmaceuticals USA recalled 2 products on 2016-12-14

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
2016-12-14
Critical
0
Units

Why these products were recalled

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

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

1–2 of 2

  • LowFDA (Drugs)··2016-12-14

    Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure

    Teva Pharmaceuticals is recalling Qnasl nasal aerosol canisters because the product failed stability testing for spray content uniformity.

    Product
    Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2016-12-14

    Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure

    Teva Pharmaceuticals USA is recalling Qnasl nasal aerosol because stability testing showed the product failed content uniformity specifications.

    Product
    Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.
    Category
    Distribution
    0 states