The Recall Desk
SevereFDA (Drugs)·D-1362-2015·Announced 2015-09-02

GlaxoSmithKline Recalls Mupirocin Calcium Cream Due to Penicillin Contamination

GlaxoSmithKline is recalling Mupirocin Calcium Cream, 2%, because the product was contaminated with penicillin and foreign substances 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, which corresponds to a Severe rating under the rubric, especially given the risk of anaphylaxis from penicillin contamination in a drug product.

Plain-English summary

GlaxoSmithKline, LLC. is recalling Mupirocin Calcium Cream, 2%, in 15g and 30g tubes. The recall involves specific lots of the prescription medication manufactured by Glaxo Operations UK Ltd. for GlaxoSmithKline.

The recall was initiated because the product was contaminated with penicillin and foreign substances during the manufacturing process. This contamination poses a risk to patients, particularly those with penicillin allergies.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or contact GlaxoSmithKline for instructions on disposal or replacement.

The recalled product

Product
Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), 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

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 (20)

  • Lot #: C690076
  • C693373
  • Exp 2/2016
  • Lot #: C701378
  • C701376
  • Exp 4/2016
  • Lot #: C704164
  • Exp 5/2016
  • Lot #: C713687
  • Exp 8/2016
  • Lot #: C719467
  • C718203
  • Exp 9/2016
  • Lot #: C723641
  • Exp 10/2016
  • Lot #: C683884
  • Exp 12/2016
  • Lot #: C697653
  • Exp 3/2016
  • Lot #: C710477

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 →