Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 table
Summary
The FDA issued a Class III for Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Eac by GlaxoSmithKline LLC. Reason: Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the.
Details
Source
Drug Recall
External ID
D-0544-2024
Action Date
2024-06-12
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
Quantity Affected: 463 Cartons
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
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-17
Company
Zebulon, NC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 113 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
GlaxoSmithKline LLC has 10 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GlaxoSmithKline LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GlaxoSmithKline LLC have FDA actions?
GlaxoSmithKline LLC has 10 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0544-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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