FDA recall D-1412-2012

GlaxoSmithKline Inc · Class II · drug

Product

Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18

Reason for recall

Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-06-04
Report date
2012-07-18
Termination date
2014-09-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Zebulon, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1412-2012