Tivicay Pd Tablet, For Suspension
FDA Recall NDC 49702-255
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Tivicay Pd (NDC 49702-255). A significant event, classified as Class III, was initiated on May 17, 2024 by Viiv Healthcare Company. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
May 17, 2024
Jun 12, 2024
463 Cartons
Recall Profile & Regulatory Data
Event ID
94634
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jan 29, 2025
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
Batch or Lot Expiration Information
Lot# : AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Affected Packages Involved in this Recall
49702-255-37Product
49702-226-13Product
49702-227-13Product
49702-228-13Product
Class III Terminated
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.
May 13, 2022
Jun 01, 2022
328 bottles
Recall Profile & Regulatory Data
Event ID
90166
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Aug 17, 2023
Product Description
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Batch or Lot Expiration Information
Lot# Lot: 2A9E, Exp 1/2027
Affected Packages Involved in this Recall
49702-255-37Product
49702-226-13Product
49702-227-13Product
49702-228-13Product
Class III Terminated
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Feb 11, 2014
Apr 09, 2014
1,056 bottles
Recall Profile & Regulatory Data
Event ID
67606
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Viiv Healthcare Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide including Puerto Rico
Termination Date
Aug 21, 2014
Product Description
Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13
Batch or Lot Expiration Information
Lot# : 3ZP2210 Sub-lot A, Expiry: 10/15
Affected Packages Involved in this Recall
49702-255-37Product
49702-226-13Product
49702-227-13Product
49702-228-13Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
