CLASS II Drug recall · Reported 27 Oct 2021 · FDA Enforcement Report
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg recalled
Teva Pharmaceuticals USA is recalling AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation, distributed nationwide in the US. The recall was initiated on 22 Sep 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0021-2022
- FDA event ID
- 88738
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2021
- FDA classified
- 21 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 22 Sep 2021 | Recall initiated by company | |
| 21 Oct 2021 | Classified by FDA | +29 days |
| 27 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Which lots are affected?
AFR17A
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 88738This product is part of a recall event; the main page for the event is AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide | |
| CLASS II | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide | |
| CLASS II | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide | |
| CLASS II | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Airduo Digihaler 113 recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |