FDA (Drugs) recall action 84978

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalled 63 products on 2020-03-11

The FDA (Drugs) publishes a recall like this one as 63 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 63 pages.

Products: 63
Announced: 2020-03-11
Critical: 0
Units: —

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

51–63 of 63

SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Testosterone Cypionate/Progesterone Injection due to a lack of assurance of sterility.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Dexamethasone Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling Dexamethasone (LA) Injectable Suspension because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Levocarnitine Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Levocarnitine Injection because the company cannot guarantee the product's sterility.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Lysine Hydrochloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Lysine Hydrochloride Injection because the company cannot ensure the product is sterile.
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
Category
Distribution
1 state
HighFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Testosterone Cypionate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Vitamin D3 Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Vitamin D3 Injection because the product may lack assurance of sterility.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Methylprednisolone Acetate/Bupivacaine Injectable Suspension
Axia Pharmaceutical is recalling Methylprednisolone Acetate/Bupivacaine Injectable Suspension due to a lack of assurance of sterility.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Calcium Chloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Calcium Chloride Injection due to a lack of assurance of sterility. The affected product was distributed nationwide and in several international locations.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Triamcinolone Acetonide Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Triamcinolone Acetonide Injectable Suspension because the company cannot ensure the product is sterile.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Arginine Hydrochloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Arginine Hydrochloride Injection because the product lacks assurance of sterility.
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
Category
Distribution
1 state
HighFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Methylcobalamin Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Methylcobalamin Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
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
Category
Distribution
1 state