D-0896-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2022
- Initiation Date
- May 13, 2022
- Termination Date
- August 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