Recalls / Class II
Class IID-1361-2015
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.
- Affected lot / code info
- 15 g: Lot #: C695549, Exp 03/2016; 30 g: Lot #: C707836, Exp 7/2016; C718209, Exp 9/2016, Expanded to include: C707837, Exp. 07/2016, C718210, Exp. 09/2016.
Why it was recalled
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Recalling firm
- Firm
- GlaxoSmithKline, LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 North Arendell Ave, N/A, Zebulon, North Carolina 27597-1217
Distribution
- Quantity
- 28,480 tubes of 15g, 12,234 tubes of 30g
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-08-13
- FDA classified
- 2015-08-25
- Posted by FDA
- 2015-09-02
- Terminated
- 2017-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1361-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.