Drug 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.
D-1362-2015
Product summary
- Event
- Event 71920
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166,070 of 15g tube, 112,720 of 30 g tube
- Official record key
drug-enforcement:D-1362-2015
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 #: C690076, C693373, Exp 2/2016; Lot #: C701378, C701376, Exp 4/2016; Lot #: C704164, Exp 5/2016; Lot #: C713687, Exp 8/2016; Lot #: C719467,C718203, Exp 9/2016; Lot #: C723641, Exp 10/2016; Lot #: C683884, Exp 12/2016; Lot #: C697653, Exp 3/2016; Lot #: C710477, Exp 7/2016; Expanded to include: C697654, Exp. 03/2016 (15 grams), C723642, Exp. 10/2016 (30 grams).
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance