Recalls / Class II
Class IID-1444-2016
Product
Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.
- Affected lot / code info
- Lot #: C686801, C689267, C692405, Exp. Jul 2016; C698116, Exp. Sep 2016; C750793, C750794, C752166, C752805 and C754828, Exp. Nov 2017.
Why it was recalled
Penicillin Cross Contamination
Recalling firm
- Firm
- GlaxoSmithKline, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 N Arendell Ave, N/A, Zebulon, North Carolina 27597-2309
Distribution
- Quantity
- 153,119 tubes
- Distribution pattern
- Nationwide and PR.
Timeline
- Recall initiated
- 2016-07-18
- FDA classified
- 2016-07-20
- Posted by FDA
- 2016-07-27
- Terminated
- 2017-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1444-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.