The Recall Desk
SevereFDA (Drugs)·D-1412-2012·Announced 2012-07-18

Trizivir Tablets Recalled Due to Potential Foreign Tablet Contamination

GlaxoSmithKline is recalling Trizivir tablets because they may contain foreign Lexiva tablets. Patients should stop using the affected lot and contact their healthcare provider.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as ingesting the wrong medication) are classified as Severe (Score 4).

Plain-English summary

GlaxoSmithKline Inc is recalling 14,465 bottles of Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, NDC 49702-217-18. The recall is due to the potential presence of foreign tablets, specifically Lexiva 700 mg tablets, within the bottles.

The affected product is identified by Lot #0ZP5128 with an expiration date of 8/2013. The recall covers a nationwide distribution of the product. Trizivir is a prescription-only medication manufactured for ViiV Healthcare by GlaxoSmithKline.

Patients and healthcare providers should stop using the affected lot of Trizivir and contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

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 units
14,465

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #0ZP5128 exp
  • 8/2013

Distribution

Distributed nationwide across the United States.

Same manufacturer · GlaxoSmithKline Inc

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