The Recall Desk
SevereFDA (Drugs)·D-1359-2015·Announced 2015-09-02

Bactroban Nasal Ointment Recalled for Penicillin Contamination

GlaxoSmithKline is recalling Bactroban Nasal Ointment due to penicillin cross-contamination and foreign substances found during manufacturing.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are listed in the text, the presence of a known allergen (penicillin) and foreign substances in a drug product warrants a high severity rating under the Class II criteria.

Plain-English summary

GlaxoSmithKline, LLC. is recalling Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tubes, because the product was contaminated with penicillin and foreign substances during the manufacturing process. The recall involves 88,489 tubes distributed nationwide and in Puerto Rico.

The affected lots include C704202, C706532, C713177, C716567, C720097, C720098, and C720096, with expiration dates ranging from November 2016 to March 2017. The product is prescription-only and was manufactured by Glaxo Operations UK Ltd. for GlaxoSmithKline.

Consumers should stop using the recalled product and return it to their pharmacy or contact their healthcare provider for further instructions.

The recalled product

Product
Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11
Manufacturer
GlaxoSmithKline, LLC.
Category
Drug — Antibiotic
Hazard
Affected units
88,489

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 (13)

  • Lot #: C704202
  • Exp 11/2016
  • Lot #: C706532
  • Exp 12/2016
  • Lot #: C713177
  • Exp 1/2017
  • Lot #: C716567
  • Exp 2/2017
  • Lot #: C720097
  • C720098
  • Exp 3/2017
  • Expanded to include: C720096
  • Exp. 2/2017.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Related recalls

Same manufacturer · GlaxoSmithKline, LLC.

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Same hazard · penicillin contamination

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