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Recall Observatory FDA recall evidence

Drug product

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

D-0544-2024

May 17, 2024

Class III

Product summary

Firm
GlaxoSmithKline LLC
Event
Event 94634
Status
Terminated
Classification
Class III
Quantity
463 Cartons
Official record key
drug-enforcement:D-0544-2024

Official wording

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 tablet bottle label, is 2025-APR.

Code information: Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect