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- Recall Enforcement Event ID: 74742
Recall Enforment Report D-1443-2016
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by GlaxoSmithKline, LLC, originally initiated on 07-18-2016 for 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, The product was recalled due to penicillin cross contamination. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1443-2016 | 07-18-2016 | 07-27-2016 | Class II | 7,480 tubes | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25, | Penicillin Cross Contamination | Terminated |
| D-1445-2016 | 07-18-2016 | 07-27-2016 | Class II | 18,000 tubes | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44, | Penicillin Cross Contamination | Terminated |
| D-1444-2016 | 07-18-2016 | 07-27-2016 | Class II | 153,119 tubes | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11. | Penicillin Cross Contamination | Terminated |
| D-1442-2016 | 07-18-2016 | 07-27-2016 | Class II | 28,131 tubes | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22, | Penicillin Cross Contamination | Terminated |
Recall Enforcement Report D-1443-2016
- Event ID
- 74742 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1443-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide and PR. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,
- Reason For Recall
- Penicillin Cross Contamination What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,480 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 07-18-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithKline, LLC
- Code Info
- Lot #: C740906, Exp. Feb 2017. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1445-2016
- Event ID
- 74742 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1445-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide and PR. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
- Reason For Recall
- Penicillin Cross Contamination What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 18,000 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 07-18-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithKline, LLC
- Code Info
- Lot #: C715275, Exp. Aug 2016. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1444-2016
- Event ID
- 74742 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1444-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide and PR. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.
- Reason For Recall
- Penicillin Cross Contamination What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 153,119 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 07-18-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithKline, LLC
- Code Info
- Lot #: C686801, C689267, C692405, Exp. Jul 2016; C698116, Exp. Sep 2016; C750793, C750794, C752166, C752805 and C754828, Exp. Nov 2017. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1442-2016
- Event ID
- 74742 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1442-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide and PR. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,
- Reason For Recall
- Penicillin Cross Contamination What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 28,131 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 07-27-2016
- Recall Initiation Date
- 07-18-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithKline, LLC
- Code Info
- Lot #: C725860, Exp. Nov 2016; C740904, Exp. Feb 2017. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
