Recalls / Class II
Class IID-1362-2015
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.
- Affected lot / code info
- 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).
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
- 166,070 of 15g tube, 112,720 of 30 g tube
- 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-1362-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.