FDA Drug Recalls

Recalls / Class II

Class IID-1412-2012

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

Affected lot / code info
Lot #0ZP5128 exp; 8/2013

Why it was recalled

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

Recalling firm

Firm
GlaxoSmithKline Inc
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1011 North Arendell Ave, P.O. Box 1217, Zebulon, North Carolina 27597-1217

Distribution

Quantity
14,465 bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2012-06-04
FDA classified
2012-07-12
Posted by FDA
2012-07-18
Terminated
2014-09-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1412-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.