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Class II: temporary or reversible health riskTerminated

GlaxoSmithKline Trizivir Recall

Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets,…

GlaxoSmithKline Inc · Zebulon, NC

Risk level
Class II
Reported by FDA
Jul 18, 2012
Recall ID
D-1412-2012
Check your lot numberHow we source this data

Summary

GlaxoSmithKline recalled Trizivir starting Jun 4, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1412-2012 on Jul 18, 2012. Reason: Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot #0ZP5128 exp; 8/2013

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1412-2012
Classification
Class II
Status
Terminated
Recall initiated
Jun 4, 2012
FDA report date
Jul 18, 2012
Quantity
14,465 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
GlaxoSmithKline Inc

Original FDA data

Every field from FDA enforcement report D-1412-2012, exactly as published.

Show all FDA fields
City
Zebulon
State
NC
Status
Terminated
Country
United States
Event ID
62392
Address
1011 North Arendell Ave
Address (line 2)
P.O. Box 1217
Code information
Lot #0ZP5128 exp; 8/2013
Postal code
27597-1217
Report date
Jul 18, 2012
Product type
Drugs
Recall number
D-1412-2012
Classification
Class II
Recalling firm
GlaxoSmithKline Inc
Product quantity
14,465 bottles
Termination date
Sep 4, 2014
Reason for recall
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Jun 4, 2012
Initial firm notification
Letter
Center classification date
Jul 12, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1412-2012, published Jul 18, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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