GlaxoSmithKline, LLC. recalls Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manu…

Recall date

August 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1361-2015

FDA classification

Class II

Brand / firm

GlaxoSmithKline, LLC.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.