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

FDA recall notice · announced April 9, 2014 · Viiv Healthcare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Cross Contamination with Other Products: Product contains Promacta (eltrombopag).

Notes

Distribution: Nationwide including Puerto Rico
Lot/code information: Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15
Quantity: 1,056 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1185-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.