CLASS II Drug recall · Reported 11 Mar 2020 · FDA Enforcement Report

Pyridoxine Hydrochloride Injection recalled by Fusion IV Pharmaceuticals

Fusion IV Pharmaceuticals is recalling Pyridoxine Hydrochloride Injection, Pyridoxine HCL 100 MG/ML Injectable, For IV, IM Use, distributed nationwide in the US. The recall was initiated on 15 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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

Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0980-2020
FDA event ID: 84978
Recalling firm: Fusion IV Pharmaceuticals, Los Angeles, CA
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2020
FDA classified: 5 Mar 2020
Reported: 11 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

15 Jan 2020	Recall initiated by company
5 Mar 2020	Classified by FDA	+50 days
11 Mar 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

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

Where was it sold?

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

62 other products · FDA event 84978

This product is part of a recall event; the main page for the event is Polyoxyl Lauryl Ether (Polidocanol) Injection, Laureth recalled.

Reported	Class	Recall	Company	Reason	Where
11 Mar 2020	CLASS II	Polyoxyl Lauryl Ether (Polidocanol) Injection, Laureth recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Betamethasone Acetate/Betamethasone recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methylprednisolone Acetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Selenium Injection, Selenium 200MCG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	AscorbiX (Buffered C) Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Glutathione Injection,Glutathione 200MG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Alprostadil (prostaglandin E1) 80 MCG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Glycine Injection,Glycine USP 50MG/ML Injectable, For IV recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methionine/Inositol/Choline Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Triamcinolone Diacetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Mic-plus Injection, Vitamin Complex recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Lidocaine HCL (PF) Injection, Lidocaine HCL recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Triamcinolone Diacetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Testosterone Cypionate/Progesterone Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Alprostadil (prostaglandin E1)150 MCG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Hydroxyprogesterone Caproate Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Human Chorionic Gonadotropin (hCG) Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Biotin (Vitamin H) Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methylcobalamin Injection, Methylcobalamin [CD] recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Cyanocobalamin/Folinic Acid Injection, Cyanocobalamin recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	AscorbiX (Buffered C) Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Dexamethasone (LA) Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Cyanocobalamin Injection, Cyanocobalamin 2000 Mcg/ML recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Levocarnitine Injection, Levocarnitine 500 MG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Lysine Hydrochloride Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	B-complex 110 Injectable, For IV, IM, SC Use recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Mitomycin-C (PF) Irrigation Solution, Mitomycin recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Testosterone Cypionate Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Testosterone Cypionate Injection,Testosterone Cyp recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Deoxycholic Acid Sodium Injection,Deoxycholic Acid Sodium recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Hydroxocobalamin Injection, Hydroxocobalamin 5MG/ML recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Cholecalciferol (Vitamin D3) Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methylprednisolone Acetate/Bupivacaine Hydrochloride recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Super Mic Injection, Super Mic* Injectable, Vitamin Complex recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methylprednisolone Acetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Triamcinolone Acetonide/Bupivacaine Hydrochloride recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Glycerin (PF) Injection,Glycerin 99% Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Calcium Chloride Injection, For IM Use, Refrigerate recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Dexpanthenol Injection, Dexpanthenol 250 MG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Cholecalciferol (Vitamin D3) Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Coenzyme Q10 Injection,Coenzyme Q-10 20MG/ML Oil Inj Soln recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Triamcinolone Acetonide (PF) Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Zinc Chloride Injection, Zinc Chloride 10MG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Triamcinolone Acetonide (PF) Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS III	Magnesium Chloride Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Nicotinamide Adenine Dinucleotide (PF) Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Iohexol (PF) Injection,Omnipaque Injection [] 300MG I/ML recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methylprednisolone Acetate/Bupivacaine Hydrochloride recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Arginine Hydrochloride Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Betamethasone Acetate/Betamethasone recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Mic-B12 Injection, Mic-B12 25MG/50MG/50MG/1MG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Mic-plex Injection, Vitamin Complex recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methylprednisolone Acetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Betamethasone Acetate/Betamethasone recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Triamcinolone Diacetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Methylcobalamin Injection, Methylcobalamin 1 MG/ML recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020	CLASS II	Nicotinamide Adenine Dinucleotide (PF) Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide

More recalls from Fusion IV Pharmaceuticals

All 64

Reported	Class	Recall	Company	Reason	Where
11 Mar 2020Drug	CLASS II	Nicotinamide Adenine Dinucleotide (PF) Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Methylcobalamin Injection, Methylcobalamin 1 MG/ML recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Triamcinolone Diacetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Betamethasone Acetate/Betamethasone recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Methylprednisolone Acetate Injectable Suspension recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide

Other Pyridoxine recalls

All 23

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022Drug	CLASS II	Pyridoxine 100 mg/mL, Multi-Dose vial recalled	Olympia Compounding Pharmacy	Sterility	Nationwide
1 Jun 2022Drug	CLASS II	Pyridoxine HCL 100 mg/mL, Multi-Dose vial recalled	Olympia Compounding Pharmacy	Sterility	Nationwide
20 Feb 2019Drug	CLASS II	Pyridoxine HCl, 100 mg/mL Injection vial recalled by Promise Pharmacy	Promise Pharmacy	Sterility	Nationwide
7 Nov 2018Drug	CLASS II	Pyridoxine 100 mg/mL MDV Injectable, Pharm D Solutions recalled	Pharm D Solutions	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Pyridoxine HCL 100 mg/ml. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide