CLASS II Drug recall · Reported 18 Jul 2012 · FDA Enforcement Report
Trizivir (abacavir sulfate 300mg, lamivudine 150 mg recalled
GlaxoSmithKline is recalling Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), distributed nationwide in the US. The recall was initiated on 4 Jun 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1412-2012
- FDA event ID
- 62392
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jun 2012
- FDA classified
- 12 Jul 2012
- Reported
- 18 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 4 Jun 2012 | Recall initiated by company | |
| 12 Jul 2012 | Classified by FDA | +38 days |
| 18 Jul 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Which lots are affected?
Lot #0ZP5128 exp; 8/2013
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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