Agency classClass IIOur severity:Severe FDA (Drugs)·D-1443-2016·Announced 2016-07-27

GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Cross Contamination

GlaxoSmithKline is recalling Bactroban Cream (Mupirocin Calcium Cream 2%) due to penicillin cross-contamination. The recall covers 7,480 tubes distributed nationwide and in Puerto Rico.

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. According to the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as allergic reactions from penicillin contamination) are rated as Severe (4).

Plain-English summary

GlaxoSmithKline, LLC is recalling Bactroban Cream (Mupirocin Calcium Cream 2%), 30 gram tubes, due to penicillin cross-contamination. The affected product is prescription-only and was manufactured in England. The specific lot number is C740906, with an expiration date of February 2017.

The recall involves 7,480 tubes of the product. These units were distributed nationwide and in Puerto Rico. The FDA has classified this recall as Class II, 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 lot of Bactroban Cream and return it to the pharmacy or point of purchase for a refund or replacement. Patients with a known penicillin allergy should be particularly cautious and consult their healthcare provider regarding alternative treatments.

The recalled product

Product: Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,
Manufacturer: GlaxoSmithKline, LLC
Category: Drug — Topical Antibiotic
Hazard: penicillin-contamination
allergic-reaction
Affected units: 7,480

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 #: C740906
Exp. Feb 2017.

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 →

Same manufacturer · GlaxoSmithKline, LLC

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Same hazard · penicillin contamination