Agency classClass IIOur severity:Severe FDA (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.

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 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: penicillin-contamination
foreign-substance

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 →

Same manufacturer · GlaxoSmithKline, LLC.

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Same hazard · penicillin contamination