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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71920

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 13, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GlaxoSmithKline, LLC.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11

D-1359-2015
Recall number
D-1359-2015
Initiated
August 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
GlaxoSmithKline, LLC.
Quantity
88,489 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Code information

Lot #: C704202, Exp 11/2016; Lot #: C706532, Exp 12/2016; Lot #: C713177, Exp 1/2017; Lot #: C716567, Exp 2/2017, Lot #: C720097, C720098, Exp 3/2017, Expanded to include: C720096, Exp. 2/2017.

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 4

Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44

D-1360-2015
Recall number
D-1360-2015
Initiated
August 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
GlaxoSmithKline, LLC.
Quantity
19,520 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Code information

Lot #: C698039, Exp 03/2016

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 4

Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.

D-1361-2015
Recall number
D-1361-2015
Initiated
August 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
GlaxoSmithKline, LLC.
Quantity
28,480 tubes of 15g, 12,234 tubes of 30g

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Code information

15 g: Lot #: C695549, Exp 03/2016; 30 g: Lot #: C707836, Exp 7/2016; C718209, Exp 9/2016, Expanded to include: C707837, Exp. 07/2016, C718210, Exp. 09/2016.

Distribution pattern

Nationwide and Puerto Rico

drug · product 4 of 4

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
Recall number
D-1362-2015
Initiated
August 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
GlaxoSmithKline, LLC.
Quantity
166,070 of 15g tube, 112,720 of 30 g tube

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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