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Recall Observatory FDA recall evidence

Drug product

Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.

D-1444-2016

July 18, 2016

Class II

Product summary

Firm
GlaxoSmithKline, LLC
Event
Event 74742
Status
Terminated
Classification
Class II
Quantity
153,119 tubes
Official record key
drug-enforcement:D-1444-2016

Official wording

Reason: Penicillin Cross Contamination

Code information: Lot #: C686801, C689267, C692405, Exp. Jul 2016; C698116, Exp. Sep 2016; C750793, C750794, C752166, C752805 and C754828, Exp. Nov 2017.

Distribution pattern: Nationwide and PR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Penicillin Cross Contamination