Drug 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
D-1359-2015
Product summary
- Event
- Event 71920
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88,489 tubes
- Official record key
drug-enforcement:D-1359-2015
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 #: C704202, Exp 11/2016; Lot #: C706532, Exp 12/2016; Lot #: C713177, Exp 1/2017; Lot #: C716567, Exp 2/2017, Lot #: C720097, C720098, Exp 3/2017, Expanded to include: C720096, Exp. 2/2017.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance