PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 2, 2015 Initiated: August 13, 2015 #D-1361-2015

Product Description

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.

Reason for Recall

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Details

Recalling Firm
GlaxoSmithKline, LLC.
Units Affected
28,480 tubes of 15g, 12,234 tubes of 30g
Distribution
Nationwide and Puerto Rico
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by GlaxoSmithKline, LLC.. Units affected: 28,480 tubes of 15g, 12,234 tubes of 30g.
Why was this product recalled?
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2015. Severity: Moderate. Recall number: D-1361-2015.