Multi-event August 2015 FDA Recall Drug by Glaxosmithkline, Llc.
This Multi-event Class II drug recall was voluntarily initiated by Glaxosmithkline, Llc. on August 13, 2015 for the product Drug. The FDA reported the reason for recall as penicillin cross contamination and presence of foreign substance. product was contaminated with penicillin and foreign substances during manufacturing process.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1360-2015
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
08-13-2015
09-02-2015
19,520 tubes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-21-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : C698039, Exp 03/2016
Recall Number: D-1362-2015
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
08-13-2015
09-02-2015
166,070 of 15g tube, 112,720 of 30 g tube
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-21-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration 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).
Recall Number: D-1361-2015
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
08-13-2015
09-02-2015
28,480 tubes of 15g, 12,234 tubes of 30g
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-21-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# 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.
Recall Number: D-1359-2015
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
08-13-2015
09-02-2015
88,489 tubes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-21-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration 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.
