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Class III: unlikely to cause harmTerminated

GlaxoSmithKline Tivicay Recall

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV…

GlaxoSmithKline LLC · Zebulon, NC

Risk level
Class III
Reported by FDA
Jun 1, 2022
Recall ID
D-0896-2022
Check your lot numberHow we source this data

Summary

GlaxoSmithKline recalled Tivicay starting May 13, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0896-2022 on Jun 1, 2022. 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 January 2027, whereas the correct expiration date is September 2026. Status: Terminated.

Why it was recalled

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.

Product description

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

Lot numbers, UPCs & expiration codes

Lot: 2A9E, Exp 1/2027

Where it was sold

Nationwide in the U.S.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0896-2022
Classification
Class III
Status
Terminated
Recall initiated
May 13, 2022
FDA report date
Jun 1, 2022
Quantity
328 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
GlaxoSmithKline LLC

Original FDA data

Every field from FDA enforcement report D-0896-2022, exactly as published.

Show all FDA fields
City
Zebulon
State
NC
Status
Terminated
Country
United States
Event ID
90166
Address
1011 N Arendell Ave
Code information
Lot: 2A9E, Exp 1/2027
Postal code
27597-2309
Report date
Jun 1, 2022
Product type
Drugs
Recall number
D-0896-2022
Classification
Class III
Recalling firm
GlaxoSmithKline LLC
Product quantity
328 bottles
Termination date
Aug 17, 2023
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Distribution pattern
Nationwide in the U.S.
Recall initiation date
May 13, 2022
Initial firm notification
Letter
Center classification date
May 25, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0896-2022, published Jun 1, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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