Product Safety Recalls

Product Recall Tracker

DOLUTEGRAVIR SODIUM Recall D-0896-2022

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

DOLUTEGRAVIR SODIUM Recall D-0896-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0896-2022
Event ID90166
BrandTIVICAY
Generic NameDOLUTEGRAVIR SODIUM
ManufacturerDOLUTEGRAVIR SODIUM
Original Package?1
Active SubstanceDOLUTEGRAVIR SODIUM
Drug RouteORAL
DistributionNationwide in the U.S.
Quantity328 bottles
Recall ReasonLabeling: 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.
Drug ClassificationClass III
Drug Code Info20220601
Product NDC49702-226 49702-255 49702-227
Drug UPC0349702228139 0349702227132 0349702226135
Recall Initiation Date20220513
Report Date20220601
Classification Date20220525
Address1011 N Arendell Ave
Zebulon, NC 27597-2309
United States
Recalling FirmGlaxoSmithKline LLC
Initial Notification Letter
Unique Ingredient Identifier1Q1V9V5WYQ
Drug Application NumberNDA204790
Structured Product Labeling (SPL ID)8f3d58d9-e71b-4339-8139-4599d2957c9c
Structured Product Labeling (SPL Set ID)63df5af3-b8ac-4e76-9830-2dbb340af922
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