Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 497
Summary
The FDA issued a Class III for Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for by GlaxoSmithKline LLC. Reason: Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of.
Details
Source
Drug Recall
External ID
D-0896-2022
Action Date
2022-06-01
Status
Terminated
Category
drug
Product Description
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Lot/Code Info: Lot: 2A9E, Exp 1/2027
Quantity Affected: 328 bottles
Reason for Recall
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.
Distribution
Nationwide in the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-13
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 101 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-0896-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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