Reported Jan 3, 2024 · Terminated
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters…
GlaxoSmithKline LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GlaxoSmithKline LLC · 410 Blackwell St · Durham, NC · 27701-3986
Is this the product you have?
- 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 codes and dates
- Lot #: 7Y9S. Exp June 2025
- Amount recalled
- 67,508 inhalers
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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