Drug 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
D-1360-2015
Product summary
- Event
- Event 71920
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,520 tubes
- Official record key
drug-enforcement:D-1360-2015
Official wording
Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Code information: Lot #: C698039, Exp 03/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance