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

FDA Recall #D-0896-2022 — Class III — May 13, 2022

Recall #D-0896-2022 Date: May 13, 2022 Classification: Class III Status: Terminated

Product Description

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

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.

Recalling Firm

GlaxoSmithKline LLC — Zebulon, NC

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

328 bottles

Distribution

Nationwide in the U.S.

Code Information

Lot: 2A9E, Exp 1/2027

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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