Why it was recalled
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Product description
Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13
Lot numbers, UPCs & expiration codes
Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15
Where it was sold
Nationwide including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1185-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 11, 2014
- FDA report date
- Apr 9, 2014
- Quantity
- 1,056 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viiv Healthcare Company
Original FDA data
Every field from FDA enforcement report D-1185-2014, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 67606
- Address
- 5 Moore Dr
- Code information
- Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15
- Postal code
- 27709-0143
- Report date
- Apr 9, 2014
- Product type
- Drugs
- Recall number
- D-1185-2014
- Classification
- Class III
- Recalling firm
- Viiv Healthcare Company
- Product quantity
- 1,056 bottles
- Termination date
- Aug 21, 2014
- Reason for recall
- Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13
- Distribution pattern
- Nationwide including Puerto Rico
- Recall initiation date
- Feb 11, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 1, 2014