FDA recall D-1185-2014

Viiv Healthcare Company · Class III · drug

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).

Distribution

Nationwide including Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-02-11
Report date: 2014-04-09
Termination date: 2014-08-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1185-2014