The Recall Desk
SevereFDA (Drugs)·D-1444-2016·Announced 2016-07-27

GlaxoSmithKline Recalls Bactroban Nasal Ointment Due to Penicillin Contamination

GlaxoSmithKline is recalling Bactroban Nasal ointment tubes due to penicillin cross-contamination. The recall covers 153,119 units distributed nationwide and in Puerto Rico.

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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of penicillin cross-contamination in a prescription medication.

Plain-English summary

GlaxoSmithKline, LLC is recalling Bactroban Nasal (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, due to penicillin cross-contamination. The affected product is prescription-only and is identified by NDC 0029-1526-11.

The recall involves 153,119 tubes distributed nationwide and in Puerto Rico. Specific lot numbers affected include C686801, C689267, C692405 (Exp. Jul 2016); C698116 (Exp. Sep 2016); and C750793, C750794, C752166, C752805, and C754828 (Exp. Nov 2017).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatments if they have been prescribed this specific product.

The recalled product

Product
Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.
Manufacturer
GlaxoSmithKline, LLC
Category
Drug — Antibiotic Ointment
Hazard
Affected units
153,119

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 (11)

  • Lot #: C686801
  • C689267
  • C692405
  • Exp. Jul 2016
  • C698116
  • Exp. Sep 2016
  • C750793
  • C750794
  • C752166
  • C752805 and C754828
  • Exp. Nov 2017.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by GlaxoSmithKline, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same manufacturer · GlaxoSmithKline, LLC

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Same hazard · penicillin contamination

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