Multi-event January 2020 FDA Recall Drug by Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical

This Multi-event Class II drug recall was voluntarily initiated by Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical on January 15, 2020 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-0943-2020 TERMINATED D-0965-2020 TERMINATED D-0991-2020 TERMINATED D-0935-2020 TERMINATED D-0956-2020 TERMINATED D-0966-2020 TERMINATED D-0982-2020 TERMINATED D-0946-2020 TERMINATED D-0947-2020 TERMINATED D-0989-2020 TERMINATED D-0940-2020 TERMINATED D-0955-2020 TERMINATED D-0985-2020 TERMINATED D-0958-2020 TERMINATED D-0948-2020 TERMINATED D-0976-2020 TERMINATED D-0975-2020 TERMINATED D-0934-2020 TERMINATED D-0970-2020 TERMINATED D-0994-2020 TERMINATED D-0978-2020 TERMINATED D-0959-2020 TERMINATED D-0960-2020 TERMINATED D-0936-2020 TERMINATED D-0990-2020 TERMINATED D-0938-2020 TERMINATED D-0941-2020 TERMINATED D-0957-2020 TERMINATED D-0971-2020 TERMINATED D-0968-2020 TERMINATED D-0984-2020 TERMINATED D-0942-2020 TERMINATED D-0973-2020 TERMINATED D-0937-2020 TERMINATED D-0950-2020 TERMINATED D-0981-2020 TERMINATED D-0993-2020 TERMINATED D-0949-2020 TERMINATED D-0961-2020 TERMINATED D-0988-2020 TERMINATED D-0983-2020 TERMINATED D-0980-2020 TERMINATED D-0932-2020 TERMINATED D-0974-2020 TERMINATED D-0969-2020 TERMINATED D-0964-2020 TERMINATED D-0967-2020 TERMINATED D-0987-2020 TERMINATED D-0933-2020 TERMINATED D-0952-2020 TERMINATED D-0992-2020 TERMINATED D-0979-2020 TERMINATED D-0977-2020 TERMINATED D-0953-2020 TERMINATED D-0962-2020 TERMINATED D-0945-2020 TERMINATED D-0939-2020 TERMINATED D-0951-2020 TERMINATED D-0963-2020 TERMINATED D-0986-2020 TERMINATED D-0954-2020 TERMINATED D-0972-2020 TERMINATED D-0944-2020 TERMINATED

Recall Number: D-0943-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-1

Batch or Lot Expiration Information

Lot# : 07092019+52610, Exp 2/6/2020; 07232019+52734, Exp 2/19/2020; 08282019+52853, 09042019+52878, 09102019+52903, Exp 3/2/2020; 09182019+52929, Exp 4/17/2020; 10092019+53082, Exp 2/28/2020, 10152019+53124; Exp 5/4/2020; 10222019+53142, Exp 2/28/2020; 10292019+53160, 11052019+53186, Exp 5/4/2020; 11202019+53257, Exp 6/19/2020; 11212019+53270, Exp 6/20/2020; 12042019+53317, Exp 7/3/2020; 12102019+53363, Exp 7/9/2020

Recall Number: D-0965-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3

Batch or Lot Expiration Information

Lot# : 09052019+52881, Exp 4/7/2020; 09302019+52977, Exp 5/2/2020; 10072019+53049, Exp 5/9/2020

Recall Number: D-0991-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1

Batch or Lot Expiration Information

Lot# : 07162019+52686, Exp 4/11/2020; 11062019+53192, Exp 8/2/2020

Recall Number: D-0935-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2

Batch or Lot Expiration Information

Lot# : 12042019+53331, Exp 1/17/2020

Recall Number: D-0956-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1

Batch or Lot Expiration Information

Lot# : 07222019+52720, Exp 1/28/2020; 09182019+52923, Exp 3/26/2020; 10232019+53148, Exp 2/28/2020; 11142019+53243, Exp 5/22/2020

Recall Number: D-0966-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0338-3

Batch or Lot Expiration Information

Lot# : 07292019+52764, Exp 1/25/2020; 07292019+52766, Exp 1/25/2020

Recall Number: D-0982-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3

Batch or Lot Expiration Information

Lot# : 11042019+53181, Exp 2/2/2020; 12122019+53376, Exp 3/11/2020

Recall Number: D-0946-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3

Batch or Lot Expiration Information

Lot# : 10302019+53166, Exp 2/15/2020

Recall Number: D-0947-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1

Batch or Lot Expiration Information

Lot# : 06032019+52353, Exp 7/29/2020; 07082019+52596, Exp 9/2/2020; 10012019+52986, Exp 8/12/2020; 12122019+53374, Exp 1/25/2021

Recall Number: D-0989-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1

Batch or Lot Expiration Information

Lot# : 10102019+53104, Exp 5/4/2020

Recall Number: D-0940-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5

Batch or Lot Expiration Information

Lot# : 08222019+52828, Exp 2/28/2020; 09092019+52889, Exp 3/17/2020; 09182019+52924, Exp 3/26/2020; 09262019+52971, Exp 4/3/2020; 10142019+53108, Exp 4/21/2020; 10212019+53136, Exp 4/28/2020; 10302019+53164, Exp 5/7/2020; 11252019+53278, Exp 6/2/2020; 11262019+53284, Exp 6/3/2020

Recall Number: D-0955-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3

Batch or Lot Expiration Information

Lot# : 07012019+52572, Exp 4/6/2020; 10102019+53106, Exp 6/30/2020

Recall Number: D-0985-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2

Batch or Lot Expiration Information

Lot# : 03042019+51685, Exp 6/26/2020

Recall Number: D-0958-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5

Batch or Lot Expiration Information

Lot# : 07302019+52772, Exp 2/25/2020

Recall Number: D-0948-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3

Batch or Lot Expiration Information

Lot# :07172019+52695, 07172019+52697, 07252019+52759, Exp 1/25/2020

Recall Number: D-0976-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8

Batch or Lot Expiration Information

Lot# : 07082019+52606, Exp 4/3/2020; 07242019+52742, Exp 7/22/2020; 07242019+52745, Exp 7/22/2020; 09112019+52907, Exp 5/31/2020; 11142019+53235, Exp 11/12/2020

Recall Number: D-0975-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0231-3

Batch or Lot Expiration Information

Lot# : 06242019+52513, Exp 1/23/2020; 06242019+52515, Exp 1/23/2020; 07252019+52756, Exp 2/23/2020; 08212019+52823, Exp 3/21/2020; 10012019+52989, Exp 5/1/2020; 11062019+53194, Exp 6/6/2020

Recall Number: D-0934-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2

Batch or Lot Expiration Information

Lot# : 12042019+53323, Exp 1/17/2020

Recall Number: D-0970-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0639-2

Batch or Lot Expiration Information

Lot# : 06102019+52398, Exp 2/24/2020

Recall Number: D-0994-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3

Batch or Lot Expiration Information

Lot# : 10302019+53170, Exp 2/9/2020

Recall Number: D-0978-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1

Batch or Lot Expiration Information

Lot# : 10082019+53069, Exp 2/28/2020

Recall Number: D-0959-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3

Batch or Lot Expiration Information

Lot# : 10242019+53154, Exp 1/22/2020

Recall Number: D-0960-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3

Batch or Lot Expiration Information

Lot# : 10152019+53126, Exp 4/6/2020

Recall Number: D-0936-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2

Batch or Lot Expiration Information

Lot# : 11112019+53208, Exp 4/29/2020

Recall Number: D-0990-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2

Batch or Lot Expiration Information

Lot# : 08272019+52845, Exp 2/23/2020; 09252019+52965, Exp 3/23/2020

Recall Number: D-0938-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2

Batch or Lot Expiration Information

Lot# : 11112019+53214, Exp 3/5/2020

Recall Number: D-0941-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3

Batch or Lot Expiration Information

Lot# : 07022019+52584, 07022019+52579, Exp 3/29/2020; 08012019+52780, 08012019+52782, Exp 4/28/2020; 11262019+53288, Exp 8/23/2020

Recall Number: D-0957-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0339-3

Batch or Lot Expiration Information

Lot# : 11042019+53179, Exp 2/18/2020

Recall Number: D-0971-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0619-1

Batch or Lot Expiration Information

Lot# : 06122019+52423, Exp 7/9/2020; 06122019+52420, Exp 7/9/2020; 07182019+52703, Exp 8/14/2020

Recall Number: D-0968-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0623-1

Batch or Lot Expiration Information

Lot# : 09042019+52874, Exp 3/2/2020

Recall Number: D-0984-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2

Batch or Lot Expiration Information

Lot# : 03062019+51706, Exp 6/28/2020

Recall Number: D-0942-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0620-2

Batch or Lot Expiration Information

Lot# : 10022019+53004, Exp 2/28/2020; 11252019+53282, Exp 6/12/2020

Recall Number: D-0973-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3

Batch or Lot Expiration Information

Lot# : 07102019+52618, Exp 2/8/2020; 09052019+52880, Exp 4/5/2020; 10012019+52983, Exp 5/1/2020; 11052019+53188, Exp 6/5/2020; 12112019+53367, Exp 7/11/2020

Recall Number: D-0937-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2

Batch or Lot Expiration Information

Lot# : 11112019+53210, Exp 4/4/2020

Recall Number: D-0950-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3

Batch or Lot Expiration Information

Lot# : 10082019+53080, Exp 6/30/2020; 11192019+53251, Exp 8/24/2020

Recall Number: D-0981-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3

Batch or Lot Expiration Information

Lot# : 11052019+53182, Exp 4/7/2020

Recall Number: D-0993-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3

Batch or Lot Expiration Information

Lot# : 04292019+52110, Exp 4/28/2020; 06252019+52525, Exp 6/24/2020; 09252019+52962, 10072019+53051, Exp 8/12/2020

Recall Number: D-0949-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3

Batch or Lot Expiration Information

Lot# : 09252019+52967, Exp 4/4/2020

Recall Number: D-0961-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3

Batch or Lot Expiration Information

Lot# : 08212019+52824, Exp 2/17/2020

Recall Number: D-0988-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1

Batch or Lot Expiration Information

Lot# : 06132019+52446, Exp 7/17/2020; 11142019+53240, Exp 12/18/2020

Recall Number: D-0983-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1

Batch or Lot Expiration Information

Lot# : 03252019+51850, Exp 7/6/2020; 04252019+52098, Exp 6/29/2020; 04292019+52108, Exp 6/29/2020; 05012019+52132, Exp 10/22/2020; 05202019+52268, Exp 11/10/2020; 05222019+52290, Exp 11/10/2020; 05302019+52334, Exp 11/20/2020; 07082019+52594, Exp 12/29/2020; 07102019+52619, Exp 12/29/2020; 07292019+52762, Exp 8/12/2020; 07312019+52778, Exp 8/12/2020; 09102019+52898, Exp 1/16/2021; 09112019+52905, Exp 1/18/2021

Recall Number: D-0980-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3

Batch or Lot Expiration Information

Lot# : 09132019+52914, Exp 2/28/2020; 09162019+52920, Exp 3/2/2020; 09192019+52939; Exp 2/28/2020; 10292019+53162, Exp 4/14/2020; 12112019+53369, Exp 5/27/2020

Recall Number: D-0932-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2

Batch or Lot Expiration Information

Lot# : 12042019+533247, Exp 1/17/2020

Recall Number: D-0974-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0233-3

Batch or Lot Expiration Information

Lot# : 11212019+53263, Exp 2/16/2020; 11252019+53276, Exp 2/20/2020

Recall Number: D-0969-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0624-1

Batch or Lot Expiration Information

Lot# : 09042019+52876, Exp 3/2/2020

Recall Number: D-0964-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5

Batch or Lot Expiration Information

Lot# : 10292019+53156, Exp 4/26/2020; 11182019+53247, Exp 5/16/2020

Recall Number: D-0967-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0331-3

Batch or Lot Expiration Information

Lot# : 07232019+52730, Exp 1/19/2020; 07232019+52732, Exp 1/19/2020; 07242019+52748, Exp 1/20/2020; 11212019+53272, Exp 5/19/2020

Recall Number: D-0987-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2

Batch or Lot Expiration Information

Lot# : 08272019+52841, Exp 2/22/2020; 09242019+52953, Exp 3/22/2020; 11072019+53198, Exp 5/5/2020; 11112019+53206, Exp 5/9/2020; 11122019+53223, Exp 5/10/2020

Recall Number: D-0933-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2

Batch or Lot Expiration Information

Lot# : 12042019+533225, Exp 1/17/2020

Recall Number: D-0952-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3

Batch or Lot Expiration Information

Lot# : 07242019+52740, Exp 1/20/2020; 11202019+53259, Exp 5/18/2020

Recall Number: D-0992-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3

Batch or Lot Expiration Information

Lot# : 04082019+51930, Exp 4/8/2020; 09092019+52891, Exp 8/12/2020

Recall Number: D-0979-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5

Batch or Lot Expiration Information

Lot# : 10012019+52984, Exp 1/19/2020

Recall Number: D-0977-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1

Batch or Lot Expiration Information

Lot# : 08282019+52850, Exp 1/24/2020; 10102019+53094, Exp 2/28/2020; 10312019+53174, Exp 3/28/2020

Recall Number: D-0953-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3

Batch or Lot Expiration Information

Lot# : 10212019+53138, Exp 11/19/2020; 10302019+53172, Exp 1/28/2020; 11122019+53225, Exp 2/10/2020

Recall Number: D-0962-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5

Batch or Lot Expiration Information

Lot# : 07012019+52569, Exp 3/15/2020

Recall Number: D-0945-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3

Batch or Lot Expiration Information

Lot# : 11132019+53229, Exp 2/10/2020

Recall Number: D-0939-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-3

Batch or Lot Expiration Information

Lot# : 07112019+52635, Exp 1/17/2020; 09092019+52890, Exp 3/17/2020

Recall Number: D-0951-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1

Batch or Lot Expiration Information

Lot# : 10022019+53002, Exp 10/1/2020

Recall Number: D-0963-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3

Batch or Lot Expiration Information

Lot# : 10222019+53144, Exp 1/27/2020

Recall Number: D-0986-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1

Batch or Lot Expiration Information

Lot# : 05292019+52328, Exp 2/13/2020

Recall Number: D-0954-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0464-1

Batch or Lot Expiration Information

Lot# : 08142019+52805, Exp 2/10/2020

Recall Number: D-0972-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0636-1

Batch or Lot Expiration Information

Lot# : 03202019+51817, Exp 4/16/2020; 09122019+52911, Exp 10/9/2020; 09132019+52918, Exp 8/12/2020

Recall Number: D-0944-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
01-15-2020
Reported
03-11-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84978
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.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-07-2023
Product Description About Product Description
Full technical description of the product.
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well. 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-5

Batch or Lot Expiration Information

Lot# : 07232019+52738, Exp 2/20/2020