PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 2, 2015 Initiated: August 13, 2015 #D-1362-2015

Product Description

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.

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
166,070 of 15g tube, 112,720 of 30 g tube
Distribution
Nationwide and Puerto Rico
Location
Zebulon, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by GlaxoSmithKline, LLC.. Units affected: 166,070 of 15g tube, 112,720 of 30 g tube.
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-1362-2015.