Multi-event July 2017 FDA Recall Drug by Cantrell Drug Company

This Multi-event Class II drug recall was voluntarily initiated by Cantrell Drug Company on July 14, 2017 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1075-2017 TERMINATED D-1068-2017 TERMINATED D-1073-2017 TERMINATED D-1071-2017 TERMINATED D-1061-2017 TERMINATED D-1067-2017 TERMINATED D-1063-2017 TERMINATED D-1070-2017 TERMINATED D-1064-2017 TERMINATED D-1079-2017 TERMINATED D-1062-2017 TERMINATED D-1076-2017 TERMINATED D-1078-2017 TERMINATED D-1066-2017 TERMINATED D-1065-2017 TERMINATED D-1072-2017 TERMINATED D-1074-2017 TERMINATED D-1069-2017 TERMINATED

Recall Number: D-1075-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
40081 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222

Batch or Lot Expiration Information

Lot# : 10349, BUD: 7/30/2017; 10356, BUD: 7/31/2017; 10377, BUD: 8/4/2017; 10386, BUD: 8/5/2017; 10394, BUD: 8/6/2017; 10404, BUD: 8/8/2017; 10423 BUD: 8/12/2017; 10468, BUD: 8/18/2017; 10473, BUD: 8/19/2017; 10482, BUD: 8/20/2017; 10514, BUD: 8/25/2017; 10524, BUD: 8/26/2017; 10569, BUD: 9/3/2017

Recall Number: D-1068-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
57430 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12

Batch or Lot Expiration Information

Lot# : 10078, BUD: 7/24/2017; 10111, BUD: 7/27/2017; 10125, BUD: 7/31/2017; 10143, BUD: 8/2/2017; 10166, BUD: 8/6/2017; 10191, BUD: 8/2/2017; 10195, BUD: 7/31/2017; 10221, BUD: 8/13/2017; 10297, BUD: 8/20/2017; 10376, BUD: 9/3/2017; 10398, BUD: 9/6/2017; 10432, BUD: 9/12/2017; 10447,10472, BUD: 9/14/2017; 10547, BUD: 9/27/2017; 10571, BUD: 10/3/2017

Recall Number: D-1073-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
2761 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13

Batch or Lot Expiration Information

Lot# : 10084, BUD: 7/25/2017; 10137, BUD: 8/2/2017; 10252, BUD: 8/15/2017; 10271, BUD: 8/17/2017; 10350, BUD: 8/30/2017; 10491, BUD: 9/21/2017

Recall Number: D-1071-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
1718 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18

Batch or Lot Expiration Information

Lot# Lot 3:: 10374, BUD: 8/4/2017; 10429, BUD: 8/13/2017; 10532, BUD: 8/27/2017

Recall Number: D-1061-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
24638 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12

Batch or Lot Expiration Information

Lot# : 9906, 9915 BUD: 7/28/2017; 9950, 9984, 10001,10010, BUD: 8/4/2017; 10064, BUD: 8/17/2017; 10341, 10452 BUD: 9/23/2017

Recall Number: D-1067-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
5245 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45

Batch or Lot Expiration Information

Lot# : 9868, BUD: 8/9/2017; 9872, BUD: 8/10/2017; 10318, BUD: 10/7/2017

Recall Number: D-1063-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
7656 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45

Batch or Lot Expiration Information

Lot# : 10099, BUD: 7/27/2017; 10127, BUD: 8/1/2017; 10208, BUD: 8/10/2017; 10254, BUD: 8/15/2017; 10278, BUD: 8/17/2017; 10303, BUD: 8/21/2017; 10371, BUD: 9/3/2017; 10457, BUD: 9/17/2017

Recall Number: D-1070-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
8928 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18

Batch or Lot Expiration Information

Lot# : 10095, BUD: 7/27/2017; 10119, BUD: 7/31/2017; 10135, BUD: 8/2/2017; 10162, BUD: 8/6/2017; 10168, BUD: 8/7/2017; 10186, BUD: 8/9/2017; 10247, BUD: 8/15/2017; 10301, BUD: 8/21/2017; 10325, BUD: 8/24/2017; 10390, BUD: 9/5/2017; 10465, BUD: 9/18/2017; 10487, BUD: 9/20/2017; 10542, BUD: 9/27/2017

Recall Number: D-1064-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
49666 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15

Batch or Lot Expiration Information

Lot# : 9904, 9914, 9939, BUD: 7/28/2017; 9952, 9969, 10004, BUD: 8/4/2017; 10043, 10088, 10115, BUD: 8/17/2017; 10269, BUD: 9/8/2017;10431, BUD: 9/23/2017; 10554, BUD: 10/27/2017

Recall Number: D-1079-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
28779 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15

Batch or Lot Expiration Information

Lot# : 9598, BUD: 8/2/2017; 9609, BUD: 8/5/2017; 9621, BUD: 8/7/2017; 9681, BUD: 8/19/2017; 9765, BUD: 9/5/2017; 10102, BUD: 10/24/2017; 10347, BUD: 11/26/2017; 10357, BUD: 11/26/2017; 10387, BUD: 12/3/2017; 10478, 10505, 10585, BUD: 12/16/2017

Recall Number: D-1062-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
25529 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15

Batch or Lot Expiration Information

Lot# : 9910, 9928, BUD: 7/28/2017; 9962, 9993, BUD: 8/4/2017; 10333, 10481, 10538, BUD: 9/23/2017

Recall Number: D-1076-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
6210 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03

Batch or Lot Expiration Information

Lot# : 9814, 9831 BUD: 9/12/2017; 10059, BUD: 10/18/2017

Recall Number: D-1078-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
120856 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15

Batch or Lot Expiration Information

Lot# : 10081, BUD: 7/25/2017; 10096, BUD: 7/27/2017; 10112, BUD: 7/30/2017; 10117, BUD: 7/31/2017; 10152, BUD: 8/3/2017; 10159, BUD: 8/6/2017; 10170, BUD: 8/7/2017; 10174, BUD: 8/8/2017; 10193, BUD: 8/9/2017; 10202, BUD: 8/10/2017; 10212, BUD: 8/13/2017; 10242, BUD: 8/15/2017; 10276, BUD: 8/17/2017; 10294, BUD: 8/20/2017; 10320, BUD: 8/23/2017; 10328, BUD: 8/24/2017; 10334, BUD: 8/28/2017; 10342, BUD: 8/29/2017; 10364, BUD: 9/3/2017; 10392, BUD: 9/6/2017; 10420, BUD: 9/11/2017; 10427, BUD: 9/12/2017; 10440, BUD: 9/14/2017; 10463, BUD: 9/18/2017; 10495, BUD: 9/22/2017; 10499, BUD: 9/24/2017; 10512, BUD: 9/25/2017; 10556, BUD: 10/1/2017; 10567, BUD: 10/3/2017; 10583, BUD: 10/6/2017

Recall Number: D-1066-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
21080 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16

Batch or Lot Expiration Information

Lot# : 9781, BUD: 7/26/2017; 9784, BUD: 7/27/2017; 9822, BUD: 8/2/2017; 9852, BUD: 8/5/2017; 10061, BUD: 9/7/2017; 10105, BUD: 9/13/2017; 10150, BUD: 9/17/2017; 10178, BUD: 9/22/2017; 10185, BUD: 9/23/2017; 10501, BUD: 11/8/2017

Recall Number: D-1065-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
75840 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15

Batch or Lot Expiration Information

Lot# : 9783, BUD: 7/27/2017; 9801, BUD: 7/29/2017; 9807, BUD: 7/30/2017; 9847, BUD: 8/4/2017; 9954, BUD: 8/20/2017; 10022, BUD: 9/1/2017; 10052, BUD: 9/6/2017; 10063, BUD: 9/7/2017; 10086, BUD: 9/9/2017; 10108, BUD: 9/13/2017; 10156, BUD: 9/20/2017; 10180, BUD: 9/22/2017; 10245, BUD: 9/29/2017; 10264, BUD: 9/30/2017; 10322, BUD: 10/8/2017; 10339, BUD: 10/13/2017; 10368, BUD: 10/18/2017; 10406, BUD: 10/25/2017; 10419, BUD: 10/26/2017; 10435, BUD: 10/28/2017; 10455, BUD: 11/1/2017; 10489, BUD: 11/5/2017; 10497, BUD: 11/6/2017; 10516, BUD: 11/9/2017; 10527, BUD: 11/10/2017; 10577, BUD: 11/19/2017

Recall Number: D-1072-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
3039 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18

Batch or Lot Expiration Information

Lot# : 10069, BUD: 7/24/2017; 10090, BUD: 7/26/2017; 10121, BUD: 7/31/2017; 10142, BUD: 8/3/2017; 10183, BUD: 8/8/2017; 10360, BUD: 8/31/2017; 10443, BUD: 9/14/2017

Recall Number: D-1074-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
46078 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12

Batch or Lot Expiration Information

Lot# : 9556, BUD: 7/26/2017; 9566, BUD: 7/30/2017; 9584, BUD; 8/1/2017; 9613, BUD: 8/6/2017; 9656, BUD: 8/14/2017; 9798, BUD: 9/11/2017; 9812, BUD: 8/31/2017; 9819, BUD: 9/16/2017; 9836, BUD: 9/17/2017; 9944, BUD: 10/3/2017; 10158, 10493, 10565, BUD: 10/30/2017

Recall Number: D-1069-2017

Reason for Recall
Lack of Sterility Assurance.
Initiated
07-14-2017
Reported
08-16-2017
Quantity
18015 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77780
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.
Cantrell Drug Company
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.
09-16-2020
Product Description About Product Description
Full technical description of the product.
Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15

Batch or Lot Expiration Information

Lot# : 10076, BUD: 7/24/2017; 10106, BUD: 7/27/2017; 10145, BUD: 8/2/2017; 10220, BUD: 8/13/2017; 10298, BUD: 8/20/2017; 10400, BUD: 9/6/2017; 10446, BUD: 9/14/2017; 10548, BUD: 9/27/2017