Multi-event October 2017 FDA Recall Drug by Banner Pharmacy Services, Llc

This Multi-event Class II drug recall was voluntarily initiated by Banner Pharmacy Services, Llc on October 10, 2017 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0023-2018 TERMINATED D-0028-2018 TERMINATED D-0022-2018 TERMINATED D-0020-2018 TERMINATED D-0026-2018 TERMINATED D-0015-2018 TERMINATED D-0027-2018 TERMINATED D-0016-2018 TERMINATED D-0024-2018 TERMINATED D-0018-2018 TERMINATED D-0019-2018 TERMINATED D-0017-2018 TERMINATED D-0021-2018 TERMINATED D-0025-2018 TERMINATED

Recall Number: D-0023-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
24306 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

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.

Recall Number: D-0028-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
481 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 072717S4, Exp 10/26/2017; 080917S2, Exp 11/8/2017; 082517S1, Exp 11/24/2017

Recall Number: D-0022-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
3550 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-0020-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
7578 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-0026-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
3136 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 082817S3, Exp. 10/14/2017

Recall Number: D-0015-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
1359 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-0027-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
2443 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 082817S2, Exp 10/14/2017

Recall Number: D-0016-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
972 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 072717S1, Exp 10/25/2017; 080217S1, 10/31/2017; 081517S2, Exp 11/13/2017; 082917S1, Exp 11/27/2017.

Recall Number: D-0024-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
2173 cassettes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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.

Recall Number: D-0018-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-0019-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
1658 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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

Recall Number: D-0017-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
9030 cassetts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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.

Recall Number: D-0021-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
966 cassettes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-0025-2018

Reason for Recall
Lack of Assurance of Sterility.
Initiated
10-10-2017
Reported
11-01-2017
Quantity
2792 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78227
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Banner Pharmacy Services, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2018
Product Description About Product Description
Full technical description of the product.
Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801

Batch or Lot Expiration Information

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.