D-0160-2024 Class III Terminated
FDA drug recall D-0160-2024 was initiated by GlaxoSmithKline LLC on Dec 12, 2023 and is designated Class III. Reason for recall: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification The recall status is terminated (terminated Sep 12, 2024). Affected quantity: 67,508 inhalers.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 3, 2024
- Initiation Date
- Dec 12, 2023
- Termination Date
- Sep 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,508 inhalers
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
Distribution pattern
Distributed Nationwide in the USA and Puerto Rico.
Code information
Lot #: 7Y9S. Exp June 2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0160-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026