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Recall Observatory FDA recall evidence

Drug product

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

D-0896-2022

May 13, 2022

Class III

Product summary

Firm
GlaxoSmithKline LLC
Event
Event 90166
Status
Terminated
Classification
Class III
Quantity
328 bottles
Official record key
drug-enforcement:D-0896-2022

Official wording

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.

Code information: Lot: 2A9E, Exp 1/2027

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: incorrect or missing