D-0896-2022 Class III Terminated
FDA drug recall D-0896-2022 was initiated by GlaxoSmithKline LLC on May 13, 2022 and is designated Class III. 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… The recall status is terminated (terminated Aug 17, 2023). Affected quantity: 328 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 1, 2022
- Initiation Date
- May 13, 2022
- Termination Date
- Aug 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 328 bottles
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.
Distribution pattern
Nationwide in the U.S.
Code information
Lot: 2A9E, Exp 1/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0896-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026