Multi-event July 2016 FDA Recall Drug by Glaxosmithkline, Llc

This Multi-event Class II drug recall was voluntarily initiated by Glaxosmithkline, Llc on July 18, 2016 for the product Drug. The FDA reported the reason for recall as penicillin cross contamination. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1442-2016 TERMINATED D-1443-2016 TERMINATED D-1445-2016 TERMINATED D-1444-2016 TERMINATED

Recall Number: D-1442-2016

Reason for Recall
Penicillin Cross Contamination
Initiated
07-18-2016
Reported
07-27-2016
Quantity
28,131 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74742
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GlaxoSmithKline, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and PR.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2017
Product Description About Product Description
Full technical description of the 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,

Batch or Lot Expiration Information

Lot# : C725860, Exp. Nov 2016; C740904, Exp. Feb 2017.

Recall Number: D-1443-2016

Reason for Recall
Penicillin Cross Contamination
Initiated
07-18-2016
Reported
07-27-2016
Quantity
7,480 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74742
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GlaxoSmithKline, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and PR.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2017
Product Description About Product Description
Full technical description of the product.
Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,

Batch or Lot Expiration Information

Lot# : C740906, Exp. Feb 2017.

Recall Number: D-1445-2016

Reason for Recall
Penicillin Cross Contamination
Initiated
07-18-2016
Reported
07-27-2016
Quantity
18,000 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74742
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GlaxoSmithKline, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and PR.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2017
Product Description About Product Description
Full technical description of the product.
Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,

Batch or Lot Expiration Information

Lot# : C715275, Exp. Aug 2016.

Recall Number: D-1444-2016

Reason for Recall
Penicillin Cross Contamination
Initiated
07-18-2016
Reported
07-27-2016
Quantity
153,119 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74742
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GlaxoSmithKline, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and PR.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2017
Product Description About Product Description
Full technical description of the product.
Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.

Batch or Lot Expiration Information

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