PlainRecalls
FDA Drug Moderate Class II Terminated

Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44

Reported: September 2, 2015 Initiated: August 13, 2015 #D-1360-2015

Product Description

Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44

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
19,520 tubes
Distribution
Nationwide and Puerto Rico
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44. Recalled by GlaxoSmithKline, LLC.. Units affected: 19,520 tubes.
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-1360-2015.