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

Biotin (Vitamin H) Injectable Suspension recalled

Fusion IV Pharmaceuticals is recalling Biotin (Vitamin H) Injectable Suspension, Biotin 10 MG/ML Inj Susp, For 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 #: 11132019+53229, Exp 2/10/2020
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-0945-2020
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

Timeline

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

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

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

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.

ReportedClassRecallCompanyReasonWhere
CLASS IIPolyoxyl Lauryl Ether (Polidocanol) Injection, Laureth recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAlprostadil/Papaverine Hydrochloride/Phentolamine Mesylate recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIBetamethasone Acetate/Betamethasone recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethylprednisolone Acetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IISelenium Injection, Selenium 200MCG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAscorbiX (Buffered C) Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
CLASS IIGlutathione Injection,Glutathione 200MG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAlprostadil (prostaglandin E1) 80 MCG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIGlycine Injection,Glycine USP 50MG/ML Injectable, For IV recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethionine/Inositol/Choline Injection recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITriamcinolone Diacetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMic-plus Injection, Vitamin Complex recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAlprostadil/Papaverine Hydrochloride/Phentolamine recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IILidocaine HCL (PF) Injection, Lidocaine HCL recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITriamcinolone Diacetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITestosterone Cypionate/Progesterone Injection recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAlprostadil (prostaglandin E1)150 MCG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIHydroxyprogesterone Caproate Injection recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIHuman Chorionic Gonadotropin (hCG) Injection recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAlprostadil/Papaverine Hydrochloride/Phentolamine Mesylate recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethylcobalamin Injection, Methylcobalamin [CD] recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IICyanocobalamin/Folinic Acid Injection, Cyanocobalamin recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAscorbiX (Buffered C) Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
CLASS IIDexamethasone (LA) Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAlprostadil/Papaverine Hydrochloride/Phentolamine recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IICyanocobalamin Injection, Cyanocobalamin 2000 Mcg/ML recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IILevocarnitine Injection, Levocarnitine 500 MG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIAlprostadil/Papaverine Hydrochloride/Phentolamine recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IILysine Hydrochloride Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
CLASS IIB-complex 110 Injectable, For IV, IM, SC Use recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMitomycin-C (PF) Irrigation Solution, Mitomycin recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITestosterone Cypionate Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
CLASS IITestosterone Cypionate Injection,Testosterone Cyp recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIDeoxycholic Acid Sodium Injection,Deoxycholic Acid Sodium recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIHydroxocobalamin Injection, Hydroxocobalamin 5MG/ML recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IICholecalciferol (Vitamin D3) Injection recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethylprednisolone Acetate/Bupivacaine Hydrochloride recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IISuper Mic Injection, Super Mic* Injectable, Vitamin Complex recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIPyridoxine Hydrochloride Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethylprednisolone Acetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITriamcinolone Acetonide/Bupivacaine Hydrochloride recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIGlycerin (PF) Injection,Glycerin 99% Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IICalcium Chloride Injection, For IM Use, Refrigerate recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIDexpanthenol Injection, Dexpanthenol 250 MG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IICholecalciferol (Vitamin D3) Injection recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IICoenzyme Q10 Injection,Coenzyme Q-10 20MG/ML Oil Inj Soln recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITriamcinolone Acetonide (PF) Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIZinc Chloride Injection, Zinc Chloride 10MG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITriamcinolone Acetonide (PF) Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIIMagnesium Chloride Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
CLASS IINicotinamide Adenine Dinucleotide (PF) Injection recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIIohexol (PF) Injection,Omnipaque Injection [] 300MG I/ML recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethylprednisolone Acetate/Bupivacaine Hydrochloride recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIArginine Hydrochloride Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
CLASS IIBetamethasone Acetate/Betamethasone recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMic-B12 Injection, Mic-B12 25MG/50MG/50MG/1MG/ML Injectable recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMic-plex Injection, Vitamin Complex recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethylprednisolone Acetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIBetamethasone Acetate/Betamethasone recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IITriamcinolone Diacetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IIMethylcobalamin Injection, Methylcobalamin 1 MG/ML recalledFusion IV PharmaceuticalsSterilityNationwide
CLASS IINicotinamide Adenine Dinucleotide (PF) Injection recalledFusion IV PharmaceuticalsSterilityNationwide

More recalls from Fusion IV Pharmaceuticals

All 64
ReportedClassRecallCompanyReasonWhere
DrugCLASS IINicotinamide Adenine Dinucleotide (PF) Injection recalledFusion IV PharmaceuticalsSterilityNationwide
DrugCLASS IIMethylcobalamin Injection, Methylcobalamin 1 MG/ML recalledFusion IV PharmaceuticalsSterilityNationwide
DrugCLASS IITriamcinolone Diacetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide
DrugCLASS IIBetamethasone Acetate/Betamethasone recalledFusion IV PharmaceuticalsSterilityNationwide
DrugCLASS IIMethylprednisolone Acetate Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide