Home / Recalls / GlaxoSmithKline LLC / D-0544-2024

D-0544-2024 Class III Terminated

Recalled by GlaxoSmithKline LLC — Zebulon, NC

Recall Details

Product Type
Drugs
Report Date
June 12, 2024
Initiation Date
May 17, 2024
Termination Date
January 29, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
463 Cartons

Product Description

Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37

Reason for Recall

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025

Other recalls by GlaxoSmithKline LLC

  • D-0160-2024 Class III — ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 (December 12, 2023)
  • D-0896-2022 Class III — Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for (May 13, 2022)
  • D-0793-2017 Class II — Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered I (May 16, 2017)
  • D-0626-2017 Class II — Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 M (March 22, 2017)
  • D-1442-2016 Class II — Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmit (July 18, 2016)
  • D-1444-2016 Class II — Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx on (July 18, 2016)
  • D-1445-2016 Class II — Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithK (July 18, 2016)
  • D-1443-2016 Class II — Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmith (July 18, 2016)
  • D-0519-2016 Class II — Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 (December 3, 2015)
  • D-1362-2015 Class II — Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 669 (August 13, 2015)