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Class II: temporary or reversible health riskTerminated

GlaxoSmithKline Bactroban Ointment Recall

Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, R…

GlaxoSmithKline, LLC · Zebulon, NC

Risk level
Class II
Reported by FDA
Jul 27, 2016
Recall ID
D-1445-2016
Check your lot numberHow we source this data

Summary

GlaxoSmithKline recalled Bactroban Ointment starting Jul 18, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1445-2016 on Jul 27, 2016. Reason: Penicillin Cross Contamination. Status: Terminated.

Why it was recalled

Penicillin Cross Contamination

Product description

Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,

Lot numbers, UPCs & expiration codes

Lot #: C715275, Exp. Aug 2016.

Where it was sold

Nationwide and PR.

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-1445-2016
Classification
Class II
Status
Terminated
Recall initiated
Jul 18, 2016
FDA report date
Jul 27, 2016
Quantity
18,000 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
GlaxoSmithKline, LLC

Original FDA data

Every field from FDA enforcement report D-1445-2016, exactly as published.

Show all FDA fields
City
Zebulon
State
NC
Status
Terminated
Country
United States
Event ID
74742
Address
1011 N Arendell Ave
Code information
Lot #: C715275, Exp. Aug 2016.
Postal code
27597-2309
Report date
Jul 27, 2016
Product type
Drugs
Recall number
D-1445-2016
Classification
Class II
Recalling firm
GlaxoSmithKline, LLC
Product quantity
18,000 tubes
Termination date
Aug 9, 2017
Reason for recall
Penicillin Cross Contamination
Voluntary / mandated
Voluntary: Firm initiated
Product description
Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
Distribution pattern
Nationwide and PR.
Recall initiation date
Jul 18, 2016
Initial firm notification
Letter
Center classification date
Jul 20, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1445-2016, published Jul 27, 2016. 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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