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.
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 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,
- Manufacturer
- GlaxoSmithKline, LLC
- Category
- Drug — Topical Antibiotic
- 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.
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