UMECLIDINIUM BROMIDE Recall D-0160-2024
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
UMECLIDINIUM BROMIDE Recall D-0160-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0160-2024 |
| Event ID | 93565 |
| Brand | ANORO ELLIPTA |
| Generic Name | UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE |
| Manufacturer | UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE |
| Original Package? | 1 |
| Active Substance | UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | Distributed Nationwide in the USA and Puerto Rico. |
| Quantity | 67,508 inhalers |
| Recall Reason | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification |
| Drug Classification | Class III |
| Drug Code Info | 20240103 |
| Product NDC | 0173-0869 |
| Recall Initiation Date | 20231212 |
| Report Date | 20240103 |
| Classification Date | 20231222 |
| Address | 410 Blackwell St Durham, NC 27701-3986 United States |
| Recalling Firm | GlaxoSmithKline LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 7AN603V4JV 40AHO2C6DG |
| Drug Application Number | NDA203975 |
| Structured Product Labeling (SPL ID) | 99500bf8-e1f7-4aff-8f8e-4d4d1a54fea0 |
| Structured Product Labeling (SPL Set ID) | 2dbd0671-c565-40c5-bf0f-e324db26799c |
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