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 Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Nicotinamide Adenine Dinucleotide (PF) Injection because the FDA determined there is a lack of assurance of sterility.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Coenzyme Q10 Injection Due to Sterility Concerns
Fusion IV Pharmaceuticals is recalling Coenzyme Q10 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
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Polidocanol Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Polidocanol Injection because the company cannot guarantee the product is sterile.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Methionine Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Methionine/Inositol/Choline Injection due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
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
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
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 Zinc Chloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Zinc Chloride Injection because the product lacks assurance of sterility.
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
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 because the product lacks assurance of sterility.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Hydroxyprogesterone Caproate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.
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
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 because the company cannot guarantee the product is sterile.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the product lacks assurance of sterility.
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
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/Atropine Injection due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.
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
Category
Distribution
1 state
SevereFDA (Drugs)··2020-03-11
Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling Betamethasone Acetate/Betamethasone Injectable Suspension due to a lack of assurance of sterility. The product was distributed nationwide and in several territories.
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…
Category
Distribution
1 state