Recalls / Class II
Class IID-1442-2016
Product
Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,
- Affected lot / code info
- Lot #: C725860, Exp. Nov 2016; C740904, Exp. Feb 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
- 28,131 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-1442-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.