Why it was recalled
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Product description
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.
Lot numbers, UPCs & expiration codes
AFR18A
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0022-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 22, 2021
- FDA report date
- Oct 27, 2021
- Quantity
- 3,240 inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0022-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88738
- Address
- 400 Interpace Pkwy
- Code information
- AFR18A
- Postal code
- 07054-1120
- Report date
- Oct 27, 2021
- Product type
- Drugs
- Recall number
- D-0022-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 3,240 inhalers
- Termination date
- Feb 16, 2023
- Reason for recall
- Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Sep 22, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2021