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
Reported: January 3, 2024 Initiated: December 12, 2023 #D-0160-2024
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
Reason for Recall
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Details
- Recalling Firm
- GlaxoSmithKline LLC
- Units Affected
- 67,508 inhalers
- Distribution
- Distributed Nationwide in the USA and Puerto Rico.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by GlaxoSmithKline LLC. Units affected: 67,508 inhalers.
Why was this product recalled? ▼
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2024. Severity: Low. Recall number: D-0160-2024.
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