Why it was recalled
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Product description
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
Lot numbers, UPCs & expiration codes
Lot #: 7Y9S. Exp June 2025
Where it was sold
Distributed Nationwide in the USA and Puerto Rico.
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-0160-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 12, 2023
- FDA report date
- Jan 3, 2024
- Quantity
- 67,508 inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline LLC
Original FDA data
Every field from FDA enforcement report D-0160-2024, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 93565
- Address
- 410 Blackwell St
- Code information
- Lot #: 7Y9S. Exp June 2025
- Postal code
- 27701-3986
- Report date
- Jan 3, 2024
- Product type
- Drugs
- Recall number
- D-0160-2024
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline LLC
- Product quantity
- 67,508 inhalers
- Termination date
- Sep 12, 2024
- Reason for recall
- Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Dec 12, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2023