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- Recall Enforcement Event ID: 77191
Recall Enforment Report D-0915-2017
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pharmedium Services, LLC, originally initiated on 02-17-2017 for the product VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 The product was recalled due to labeling: not elsewhere classified: incorrect volume printed on the product label.. 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-0915-2017 | 02-17-2017 | 06-21-2017 | Class II | 60 bags | VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0906-2017 | 02-17-2017 | 06-21-2017 | Class III | 216 bags | Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0914-2017 | 02-17-2017 | 06-21-2017 | Class II | 816 bags | VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0909-2017 | 02-17-2017 | 06-21-2017 | Class III | 192 bags | Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0911-2017 | 02-17-2017 | 06-21-2017 | Class III | 672 bags | Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0907-2017 | 02-17-2017 | 06-21-2017 | Class III | 143 bags | Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0913-2017 | 02-17-2017 | 06-21-2017 | Class III | 216 bags | Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0910-2017 | 02-17-2017 | 06-21-2017 | Class III | 912 bags | Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0912-2017 | 02-17-2017 | 06-21-2017 | Class III | 48 bags | Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0916-2017 | 02-17-2017 | 06-21-2017 | Class II | 108 bags | VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
| D-0908-2017 | 02-17-2017 | 06-21-2017 | Class II | 144 bags | Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Terminated |
Recall Enforcement Report D-0915-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0915-2017 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 in the USA 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
- VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 60 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 170160016S, 2/20/2017; 170240147S, 3/1/2017; 170380016S, 3/15/2017; 170450010S, 3/22/2017 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-0906-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0906-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 in the USA 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
- Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 216 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 70090135M, 2/27/2017; 170250101M, 3/15/2017; 170030011D, 4/4/2017; 170040078D, 4/5/2017; 170310012D, 5/2/2017; 170400046D, 5/11/2017; 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-0914-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0914-2017 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 in the USA 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
- VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 816 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 170200039S, 2/22/2017; 170230182S, 170230137S, 2/23/2017; 170260122S, 2/26/2017; 170300085S, 3/2/2017; 170320048S, 3/4/2017; 170340152S, 3/8/2017; 170380097S, 3/10/2017 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-0909-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0909-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 in the USA 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
- Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 192 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 163640146S, 3/30/2017; 170020187S, 4/3/2017; 170100120S, 4/11/2017; 170200117S, 4/23/2017; 170340009S, 5/6/2017 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-0911-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0911-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 in the USA 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
- Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 672 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 163640076D, 3/30/2017; 170040009D, 4/5/2017; 170040224S, 4/5/2017; 170040065S, 4/5/2017; 170050068D, 4/6/2017; 170060353S, 4/9/2017; 170100076D, 4/11/2017; 170100111S, 4/11/2017; 170120090D, 4/13/2017; 170120154S, 4/13/2017; 170160150S, 4/17/2017; 170260005D, 4/27/2017; 170380110S, 5/9/2017; 170400085S, 5/11/2017 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-0907-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0907-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 in the USA 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
- Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 143 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 163640167M, 3/21/2017; 170050171M, 3/28/2017; 170070172M, 3/31/2017;170190235M, 4/11/2017; 170200120M, 4/14/2017; 170230115M, 4/15/2017; 170390059D, 5/10/2017; 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-0913-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0913-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 in the USA 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
- Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 216 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 163640084D, 3/30/2017; 170120081D, 4/13/2017; 170160062D, 4/17/2017; 170200066D, 4/23/2017; 170370011D, 5/8/2017 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-0910-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0910-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 in the USA 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
- Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 912 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 170050001D, 4/5/2017; 170040025D, 4/5/2017; 170060046D, 4/9/2017; 170090062D, 4/10/2017; 170110125S, 4/12/2017; 170170016S, 4/18/2017; 170200120S, 4/23/2017; 170380108S, 5/9/2017; 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-0912-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0912-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 in the USA 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
- Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 48 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 170100124S, 4/11/2017; 170390015S, 5/10/2017 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-0916-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0916-2017 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 in the USA 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
- VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 108 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 170250124S, 2/25/2017; 170270018S, 2/28/2017; 170380015S, 3/10/2017 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-0908-2017
- Event ID
- 77191 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0908-2017 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 in the USA 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
- Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Reason For Recall
- Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 144 bags 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
- 06-21-2017
- Recall Initiation Date
- 02-17-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-13-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmedium Services, LLC
- Code Info
- Lot Numbers: 170020074D, 4/3/2017; 170050071D, 4/6/2017; 170270036D, 4/30/2017 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.
