The Recall Desk
SevereFDA (Drugs)·D-1361-2015·Announced 2015-09-02

GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Contamination

GlaxoSmithKline is recalling Bactroban Cream (mupirocin calcium) 2% because the product was contaminated with penicillin and foreign substances 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as penicillin contamination in a drug product) are categorized as Severe.

Plain-English summary

GlaxoSmithKline, LLC. is recalling Bactroban Cream (mupirocin calcium), 2%, in 15g and 30g tubes. The recall involves 28,480 tubes of the 15g size and 12,234 tubes of the 30g size. The product was distributed nationwide and in Puerto Rico.

The recall was initiated because the product was contaminated with penicillin and foreign substances during the manufacturing process. The affected lots are: 15g Lot C695549 (Exp 03/2016); 30g Lots C707836 (Exp 7/2016), C718209 (Exp 9/2016), C707837 (Exp. 07/2016), and C718210 (Exp. 09/2016).

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
Manufacturer
GlaxoSmithKline, LLC.
Category
Drug — Topical Antibiotic
Hazard

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 (10)

  • 15 g: Lot #: C695549
  • Exp 03/2016
  • 30 g: Lot #: C707836
  • Exp 7/2016
  • C718209
  • Exp 9/2016
  • Expanded to include: C707837
  • Exp. 07/2016
  • C718210
  • Exp. 09/2016.

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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