The Recall Desk
SevereFDA (Drugs)·D-1445-2016·Announced 2016-07-27

GlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination

GlaxoSmithKline is recalling 18,000 tubes of Bactroban Ointment because of penicillin cross-contamination. The affected product is 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury or property damage reports, or when the agency's classification mandates a minimum score of 4.

Plain-English summary

GlaxoSmithKline, LLC is recalling 18,000 tubes of Bactroban Ointment (Mupirocin Ointment 2%), 22 gram tube, Rx only. The product is identified by NDC 0029-1525-44, Lot # C715275, and an expiration date of August 2016. The recall is due to penicillin cross-contamination.

The affected product was distributed nationwide and in Puerto Rico. The source text does not specify the number of reported illnesses or injuries associated with this recall.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
Affected units
18,000

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 (2)

  • Lot #: C715275
  • Exp. Aug 2016.

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 →