Status
Terminated
Drug Enforcement D-0544-2024
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.
Classification
Class III
Report Date
June 12, 2024
Termination Date
January 29, 2025
Product Information
- 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
- Product quantity
- 463 Cartons
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- GlaxoSmithKline LLC
- Address
-
1011 N Arendell Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0544-2024
- Event ID
- 94634
- Recall initiation date
- May 17, 2024
- Center classification date
- June 6, 2024
- Code info
- Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025
- More code info
- —