GlaxoSmithKline LLC

3 FDA enforcement actions

3 Total Recalls

0 Class I

0 Class II

3 Class III

Firm Details

Product Types: drug
States: NC

All Recalls

Class III: Low Risk 05/17/2024 drug

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III: Low Risk 12/12/2023 drug

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class III: Low Risk 05/13/2022 drug

Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.