Home / Recalls / GlaxoSmithKline LLC / D-0160-2024

D-0160-2024 Class III Terminated

Recalled by GlaxoSmithKline LLC — Durham, NC

Recall Details

Product Type: Drugs
Report Date: January 3, 2024
Initiation Date: December 12, 2023
Termination Date: September 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

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D-1442-2016 Class II — Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmit (July 18, 2016)
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D-1362-2015 Class II — Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 669 (August 13, 2015)