The Recall Desk

FDA (Drugs) recall action 71920

GlaxoSmithKline, LLC. recalled 4 products on 2015-09-02

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2015-09-02
Critical
0
Units
108,009

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Drugs)··2015-09-02

    GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Contamination

    GlaxoSmithKline is recalling Bactroban Cream (mupirocin calcium) 2% because the product was contaminated with penicillin and foreign substances during manufacturing.

    Product
    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.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-09-02

    Bactroban Nasal Ointment Recalled for Penicillin Contamination

    GlaxoSmithKline is recalling Bactroban Nasal Ointment due to penicillin cross-contamination and foreign substances found during manufacturing.

    Product
    Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-09-02

    Bactroban Ointment Recalled for Penicillin Contamination and Foreign Substances

    GlaxoSmithKline is recalling Bactroban Ointment due to penicillin cross-contamination and foreign substances found during manufacturing.

    Product
    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
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-09-02

    GlaxoSmithKline Recalls Mupirocin Calcium Cream Due to Penicillin Contamination

    GlaxoSmithKline is recalling Mupirocin Calcium Cream, 2%, because the product was contaminated with penicillin and foreign substances during manufacturing.

    Product
    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.
    Category
    Distribution
    1 state