The Recall Desk

FDA (Drugs) recall action 88738

Teva Pharmaceuticals USA recalled 5 products on 2021-10-27

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2021-10-27
Critical
0
Units
26,233

Why these products were recalled

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

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.

1–5 of 5

  • ModerateFDA (Drugs)··2021-10-27

    AirDuo Digihaler inhalation powder subpotent drug recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some batches do not deliver the labeled amount of salmeterol, a critical active ingredient for asthma and COPD control.

    Product
    AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-10-27

    AirDuo Digihaler 113/14 Inhalation Powder Subpotent Drug Recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some units contain less salmeterol than the labeled dose. The affected sample batch was distributed nationwide.

    Product
    AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-10-27

    AirDuo Digihaler 55/14 Inhalation Powder Recalled for Subpotent Dose

    Teva Pharmaceuticals is recalling AirDuo Digihaler 55/14 inhalation powder due to subpotent emitted dose of salmeterol. Approximately 1,978 inhalers distributed nationwide may deliver less medication than labeled.

    Product
    AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-10-27

    AirDuo Digihaler 232/14 Inhalation Powder Subpotent Recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 232/14 inhalation powder because some units do not deliver the correct amount of salmeterol as labeled.

    Product
    AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-10-27

    AirDuo Digihaler 232/14 Inhalation Powder Recall for Subpotent Salmeterol

    Teva Pharmaceuticals is recalling approximately 5,500 units of AirDuo Digihaler 232/14 inhalation powder distributed nationwide because some inhalers contain less salmeterol than the labeled dose.

    Product
    AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
    Category
    Distribution
    0 states