Multi-event March 2022 FDA Recall Drug by Athenex Pharma Solutions, Llc

This Multi-event Class II drug recall was voluntarily initiated by Athenex Pharma Solutions, Llc on March 14, 2022 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0710-2022 TERMINATED D-0711-2022 TERMINATED D-0712-2022 TERMINATED D-0709-2022 TERMINATED D-0708-2022 TERMINATED D-0707-2022 TERMINATED D-0706-2022 TERMINATED

Recall Number: D-0710-2022

Reason for Recall
Defective container
Initiated
03-14-2022
Reported
03-30-2022
Quantity
1,800 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89779
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.
Athenex Pharma Solutions, 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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15

Batch or Lot Expiration Information

Lot# : F2101652, F2101653, Exp 5/30/22; F2200111, Exp 7/27/22

Recall Number: D-0711-2022

Reason for Recall
Defective container
Initiated
03-14-2022
Reported
03-30-2022
Quantity
1,980 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89779
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.
Athenex Pharma Solutions, 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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15

Batch or Lot Expiration Information

Lot# : F2101654, Exp 5/30/22; F2101834, Exp 7/03/22; F2200110, Exp 7/27/22

Recall Number: D-0712-2022

Reason for Recall
Defective container
Initiated
03-14-2022
Reported
03-30-2022
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89779
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.
Athenex Pharma Solutions, 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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15

Batch or Lot Expiration Information

Lot# : F2101780, F2101781, Exp 6/21/22

Recall Number: D-0709-2022

Reason for Recall
Defective container
Initiated
03-14-2022
Reported
03-30-2022
Quantity
670 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89779
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.
Athenex Pharma Solutions, 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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15

Batch or Lot Expiration Information

Lot# : F2101651, Exp 5/30/22

Recall Number: D-0708-2022

Reason for Recall
Defective container
Initiated
03-14-2022
Reported
03-30-2022
Quantity
9,800 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89779
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.
Athenex Pharma Solutions, 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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15

Batch or Lot Expiration Information

Lot# : F2101639, F2101642, F2101644, F2101645, Exp 4/30/22; F2101674, F2101675, F2101676, Exp 5/05/22; F2101790, F2101791, F2101792, F2101793, F2101794, Exp 5/26/22; F2101813, Exp 5/29/22

Recall Number: D-0707-2022

Reason for Recall
Defective container
Initiated
03-14-2022
Reported
03-30-2022
Quantity
5,320 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89779
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.
Athenex Pharma Solutions, 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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15

Batch or Lot Expiration Information

Lot# : F2101634, Exp 3/30/22; F2101665, F2101666, Exp 4/02/22; F2101788, F2101789, Exp 4/26/22; F2101811, F2101812, F2101815, Exp 4/29/22

Recall Number: D-0706-2022

Reason for Recall
Defective container
Initiated
03-14-2022
Reported
03-30-2022
Quantity
4,270 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89779
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.
Athenex Pharma Solutions, 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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15

Batch or Lot Expiration Information

Lot# : F2101628, F2101629, F2101630, F2101631, Exp 4/28/22; F2101632, F2101633, Exp 4/29/22; F2101795, F2101796, Exp 5/27/22