GlaxoSmithKline LLC FDA Recalls

3 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tableClass IIIMay 17, 2024Labeling: Incorrect Lot and/or Expiration Date: The carton h	Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the	Class IIIDrugs	May 17, 2024
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters Class IIIDec 12, 2023Failed Release Testing: Coarse Particle Mass for umeclidiniu	Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification	Class IIIDrugs	Dec 12, 2023
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 497Class IIIMay 13, 2022Labeling: incorrect or missing lot and/or expiration date. A	Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the pro	Class IIIDrugs	May 13, 2022