← FDA ENFORCEMENT
D-0544-2024Class III

GlaxoSmithKline LLC

Recalling firm
GlaxoSmithKline LLC
Product type
Drug
Status
Terminated
Report date
2024-06-12
Distribution
Nationwide within the United States
Firm state
NC
Product quantity
463 Cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.