The Recall Desk
SevereFDA (Drugs)·D-1360-2015·Announced 2015-09-02

Bactroban Ointment Recalled for Penicillin Contamination and Foreign Substances

GlaxoSmithKline is recalling Bactroban 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk contamination (penicillin is a major allergen) are rated as Severe (4).

Plain-English summary

GlaxoSmithKline, LLC. is recalling 19,520 tubes of Bactroban Ointment (mupirocin calcium), 2%, 22g, prescription only. The product is identified by Lot # C698039 and an expiration date of 03/2016. The recall covers distribution nationwide and in Puerto Rico.

The recall was initiated because the product was contaminated with penicillin and foreign substances during the manufacturing process. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. Patients with a known penicillin allergy should be particularly cautious and consult their healthcare provider immediately if they have used the product.

The recalled product

Product
Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44
Manufacturer
GlaxoSmithKline, LLC.
Category
Drug — Topical Antibiotic
Hazard
Affected units
19,520

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 #: C698039
  • Exp 03/2016

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.

See all →

Same hazard · penicillin contamination

See all →