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- Recall Enforcement Event ID: 78227
Recall Enforment Report D-0023-2018
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Banner Pharmacy Services, LLC, originally initiated on 10-10-2017 for the product OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101 The product was recalled due to lack of assurance of sterility.. 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-0023-2018 | 10-10-2017 | 11-01-2017 | Class II | 24306 units | OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101 | Lack of Assurance of Sterility. | Terminated |
| D-0028-2018 | 10-10-2017 | 11-01-2017 | Class II | 481 bags | Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801 | Lack of Assurance of Sterility. | Terminated |
| D-0022-2018 | 10-10-2017 | 11-01-2017 | Class II | 3550 bags | Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501 | Lack of Assurance of Sterility. | Terminated |
| D-0020-2018 | 10-10-2017 | 11-01-2017 | Class II | 7578 bags | Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201 | Lack of Assurance of Sterility. | Terminated |
| D-0026-2018 | 10-10-2017 | 11-01-2017 | Class II | 3136 bags | VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501 | Lack of Assurance of Sterility. | Terminated |
| D-0015-2018 | 10-10-2017 | 11-01-2017 | Class II | 1359 bags | Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601 | Lack of Assurance of Sterility. | Terminated |
| D-0027-2018 | 10-10-2017 | 11-01-2017 | Class II | 2443 bags | VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001 | Lack of Assurance of Sterility. | Terminated |
| D-0016-2018 | 10-10-2017 | 11-01-2017 | Class II | 972 syringes | ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801 | Lack of Assurance of Sterility. | Terminated |
| D-0024-2018 | 10-10-2017 | 11-01-2017 | Class II | 2173 cassettes | Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301 | Lack of Assurance of Sterility. | Terminated |
| D-0018-2018 | 10-10-2017 | 11-01-2017 | Class II | N/A | fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001 | Lack of Assurance of Sterility. | Terminated |
| D-0019-2018 | 10-10-2017 | 11-01-2017 | Class II | 1658 syringes | Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001. | Lack of Assurance of Sterility. | Terminated |
| D-0017-2018 | 10-10-2017 | 11-01-2017 | Class II | 9030 cassetts | fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001 | Lack of Assurance of Sterility. | Terminated |
| D-0021-2018 | 10-10-2017 | 11-01-2017 | Class II | 966 cassettes | Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201 | Lack of Assurance of Sterility. | Terminated |
| D-0025-2018 | 10-10-2017 | 11-01-2017 | Class II | 2792 syringes | Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801 | Lack of Assurance of Sterility. | Terminated |
Recall Enforcement Report D-0023-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0023-2018 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 within the US 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
- OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 24306 units 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot#: 072017S4, Exp 11/16/2017; 072117S2, Exp 11/17/2017; 072417S2, Exp 11/20/2017; 072717S5, Exp 11/23/2017; 072817S3, Exp 11/24/2017; 073117S3, Exp 11/27/2017; 080217S3, Exp 11/29/2017; 080317S3, Exp 11/30/2017; 080917S3, Exp 12/6/2017; 081117S4, Exp 12/8/2017; 081717S3, Exp 12/14/2017; 081817S1, Exp 12/15/2017; 082217S3, Exp 12/19/2017; 082317S3, 082317S5, Exp 12/20/2017; 082417S3, Exp 12/21/2017; 082517S2, Exp 12/22/2017. 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-0028-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0028-2018 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 within the US 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
- Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 481 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 072717S4, Exp 10/26/2017; 080917S2, Exp 11/8/2017; 082517S1, Exp 11/24/2017 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-0022-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0022-2018 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 within the US 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
- Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3550 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 071217S2, Exp 10/11/2017; 071417S1, Exp 10/13/2017; 071917S2, 071917S3, Exp 10/18/2017; 072117S1, Exp 10/20/2017; 072617S2, 072617S3, Exp 10/25/2017; 072817S2, Exp 10/27/2017; 073117S2, 10/30/2017; 080217S2, Exp 11/1/2017; 080717S2, Exp 11/6/2017; 081117S2, Exp 11/10/2017; 081417S2, Exp 11/13/2017; 081617S2, Exp 11/15/2017; 082217S2, Exp 11/21/2017; 082317S2, Exp 11/22/2017 ; 082917S2, Exp 11/28/2019 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-0020-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0020-2018 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 within the US 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
- Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7578 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 042017S4, Exp 10/20/2017; 042517S2, 10/25/2017; 042617S3, Exp 10/26/2017; 050317S2, Exp 11/2/2017; 050517S3, Exp 11/4/2017; 051217S2, Exp 11/11/2017; 051917S1,Exp 11/18/2017; 052917S4, Exp 11/28/2017; 061317S5, Exp 12/13/2017; 061617S1, Exp 12/16/2017; 062317S1, Exp 12/23/2017; 062817S2, 12/28/2017; 062917S1, Exp 12/29/2017; 070717S1, Exp 1/6/2018; 071317S4, Exp 1/12/2018; 072017S3, Exp 1/19/2018; 072617S6, Exp 1/25/2018; 072717S3, Exp 1/26/2018; 073117S1, Exp 1/30/2018; 080317S2, Exp 2/2/2018; 080717S1, Exp 2/6/2018; 081017S3, Exp 2/9/2018; 081717S2, Exp 2/16/2018; 082417S2, 082417S5 Exp 2/23/2018; 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-0026-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0026-2018 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 within the US 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 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3136 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 082817S3, Exp. 10/14/2017 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-0015-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0015-2018 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 within the US 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
- Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1359 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 071817S1, Exp 10/18/2017; 072417S1, Exp 10/24/2017; 072517S1, Exp 10/25/2017; 081117S1, Exp 11/11/2017; 081517S1, Exp 11/15/2017; 082217S1, Exp 11/22/2017 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-0027-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0027-2018 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 within the US 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 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2443 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 082817S2, Exp 10/14/2017 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-0016-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0016-2018 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 within the US 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
- ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 972 syringes 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 072717S1, Exp 10/25/2017; 080217S1, 10/31/2017; 081517S2, Exp 11/13/2017; 082917S1, Exp 11/27/2017. 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-0024-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0024-2018 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 within the US 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
- Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2173 cassettes 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 041117S2, Exp 10/11/2017; 041817S3, Exp 10/18/2017; 042517S3, 10/25/2017; 050117S2, Exp 10/3102/17; 053017S3, Exp 11/29/2017; 060117S3, Exp 12/1/2017; 060617S3, Exp 12/6/2017; 061217S1, 12/12/2017; 062017S3, Exp 12/20/2017; 062717S2, Exp 12/27/2017; 062817S3, Exp 12/28/2017; 071117S2, Exp 1/10/2018; 071817S3, Exp 1/17/2018; 072117S3, Exp 1/20/2018; 072417S3, Exp 1/23/2018; 072517S3, Exp 1/24/2018; 080217S4, Exp 2/1/2018; 081117S3, Exp 2/10/2018; 081817S2, Exp 2/17/2018; 082317S4, Exp 2/22/2018. 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-0018-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0018-2018 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 within the US 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
- fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot # :051717S1, Exp 11/13/2017; 052417S1, Exp 11/20/2017; 062117S1, Exp 12/18/2017; 071217S1, Exp. 1/8/2017; 071917S1, Exp 1/15/2018; 072617S1, Exp 1/22/2018; 081017S1, Exp 2/6/2018 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-0019-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0019-2018 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 within the US 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
- Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1658 syringes 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 041817S5, Exp 10/15/2017; 052417S2, Exp 11/20/2017; 071117S4, Exp 1/7/2018; 0712217S4, Exp 1/8/2018; 080317S6, Exp 1/30/2018; 082217S5, Exp 2/1/2018 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-0017-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0017-2018 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 within the US 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
- fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9030 cassetts 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 041317S1, Exp 10/10/2017; 041817S1, Exp 10/15/2017; 042017S1, 10/17/2017; 042517S1, 10/22/2017; 042717S1, Exp 10/24/2017; 050217S1, Exp 10/29/2017; 050417S2, Exp 10/31/2017; 050917S1, 11/5/2017; 051117S1, 051117S4,11/7/2017; 051617S1, 11/12/2017; 051817S1, Exp 11/14/2017; 052317S1, Exp 11/19/2017; 053017S1, Exp 11/26/2017; 060617S1, Exp 12/3/2017; 060917S1, Exp 12/6/2017; 061317S1, Exp 12/10/2017; 061517S2, Exp 12/12/2017; 062017S1, Exp 12/17/2017; 062217S1, Exp 12/19/2017; 062717S1, Exp 12/24/2017; 62817S1, Exp 12/25/2017; 070417S1, Exp 12/31/2017; 070517S1, Exp 1/1/2018; 071317S1, Exp 1/7/2018; 071817S2, Exp 1/14/2018; 072017S1,Exp 1/16/2018; 72517S2, Exp 1/21/2018; 080817S1, Exp 2/4/2018; 080917S1, Exp 2/5/2018; 081617S1, Exp 2/12/2018; 081717S1, Exp 2/13/2018. 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-0021-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0021-2018 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 within the US 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
- Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 966 cassettes 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 042617S4, Exp 10/23/2017; 060817S1, Exp 12/5/2017; 070517S2, Exp 1/1/2018; 072817S1, Exp 1/24/2018; 080117S2, Exp 1/28/2018; 083017S1, Exp, 2/26/2018 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-0025-2018
- Event ID
- 78227 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0025-2018 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 within the US 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
- Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801
- Reason For Recall
- Lack of Assurance of Sterility. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2792 syringes 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
- 11-01-2017
- Recall Initiation Date
- 10-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 08-09-2018 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
- Banner Pharmacy Services, LLC
- Code Info
- Lot #: 071917S5 Exp 10/17/2017; , 072717S7, Exp 10/25/2017; 080817S3, Exp 11/6/2017; 082317S6, Exp 11/21/2017; 082417S6, Exp 11/22/2017; 082517S3, Exp 11/23/2017. 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.
