Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: penicillin-contamination
foreign-substance
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 →

Same manufacturer · GlaxoSmithKline, LLC.

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Same hazard · penicillin contamination