Drug Enforcement D-1412-2012

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

Status

Terminated

Classification

Class II

Report Date

July 18, 2012

Termination Date

September 4, 2014

Product Information

Product description
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
Product quantity
14,465 bottles
Reason for recall
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
GlaxoSmithKline Inc
Address
1011 North Arendell Ave, P.O. Box 1217

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1412-2012
Event ID
62392
Recall initiation date
June 4, 2012
Center classification date
July 12, 2012
Code info
Lot #0ZP5128 exp; 8/2013
More code info
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