Pharmacy Level Recall - Bactroban® Cream (mupirocin calcium 2%) and Bactroban® Nasal Ointment (mupirocin calcium 2%)

 

GSK Australia, in consultation with the Therapeutic Goods Administration (TGA), is initiating a pharmacy level recall of five batches of Bactroban Cream and three batches of Bactroban Nasal Ointment.

GSK is undertaking this recall due to the potential for physical particulate (sub-visible) contamination of the Active Pharmaceutical Ingredient (API) used in the manufacture of Bactroban Cream and Bactroban Nasal Ointment.

GSK's medical assessment concluded that based on all available information, the benefit risk profile of Bactroban remains positive.

Bactroban Cream is an antibiotic which can be used to treat small wounds which have become infected. Bactroban Cream is for use on your skin only.

Bactroban Nasal Ointment is used to remove bacteria, including the bacteria called 'Staphylococcus aureus' from inside your nose. Bactroban Nasal Ointment is for use in your nose only.

The implicated batches of Bactroban Cream and Bactroban Nasal Ointment are listed below. No other batches of Bactroban are implicated.

 

Product

Batch Number

Expiry

Bactroban Cream

C685907

Jan-16

Bactroban Cream

C692806

Feb-16

Bactroban Cream

C697025

Mar-16

Bactroban Cream

C697657

Mar-16

Bactroban Cream

C702376

Apr-16

 

Product

Batch Number

Expiry

Bactroban Nasal Ointment

C684916

Jul-17

Bactroban Nasal Ointment

C697795

Sept-17

Bactroban Nasal Ointment

C702770

Oct-17

 

Long term supply of Bactroban Cream and Nasal Ointment may be impacted. For current information on Bactroban availability please visit the TGA medicines shortage website.

Patients who have any questions or concerns about this issue, should talk to their doctor or other health professional.

Doctors and pharmacists who require additional information should contact GSK Medical Information on 1800 033 109.

GSK sincerely regrets the inconvenience that this recall may cause to patients, pharmacists and doctors.

 

- ENDS -

 

For medical enquiries please contact GSK Medical Information on 1800 033 109

 

For media enquiries please contact:

Kim O’Donohue, Communications Manager Pharmaceuticals

0477 322 431

kim.j.odonohue@gsk.com