CLASS II Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report

Mitomycin 20 mg Injectable, Lyophilized (Buffered) vial recalled

Wells Pharmacy Network is recalling Mitomycin 20 mg Injectable, Lyophilized (Buffered) vial, Kit, Compounded by Wells, distributed nationwide in the US. The recall was initiated on 21 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@84, 07012016@107. Known vial lot code: 04212016@149, 06082016@7.

Quantity recalled315 kits (number of vials per kit vary by prescription)

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-0379-2017
FDA event ID: 75289
Recalling firm: Wells Pharmacy Network, Ocala, FL
Classification: Class II
Status: Terminated
Recall initiated: 21 Sep 2016
FDA classified: 4 Jan 2017
Reported: 11 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

21 Sep 2016	Recall initiated by company
4 Jan 2017	Classified by FDA	+105 days
11 Jan 2017	Published in enforcement report	+7 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

Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@84, 07012016@107. Known vial lot code: 04212016@149, 06082016@7.

Where was it sold?

Nationwide

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

96 other products · FDA event 75289

This product is part of a recall event; the main page for the event is Alprostadil 20 mcg/mL Injectable, a) and b) vials recalled.

Reported	Class	Recall	Company	Reason	Where
11 Jan 2017	CLASS II	Alprostadil 20 mcg/mL Injectable, a) and b) vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	QUAD1(Pap/Phen/Alpros/Atro) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP 9 mg/3 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Sesame Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Forskolin/Papav/Phen/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Glutamine/Orni/Arginine/Lys/Citru+Lido 75 mg/75 mg/150 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin, Lyophilized Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Mitomycin 40 mg Injectable, Lyophilized (Buffered) vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix Injectable 30 mg/2 mg/20 mcg, a) and b) vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC/B-complex 15 mg/50 mg/100 mg/mL Injectable vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Grapeseed Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Glutamine/Orni/Argin/Lysine/Lido Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix Injectable 30 mg/1 mg/10 mcg/mL a) and b) recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	QUAD3 (Pap/Phen/Alpro/Atro) 30 mg/3 mg/30 mcg/ Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP Kit 6 mg/4.5 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin, Lyophilized Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sodium Bicarbonate, 8.4% Injectable MultiDose vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP 3 mg/4.5 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP & 9 mg/9 mg/9 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Mitomycin Solution Injectable, Sterile recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Carnitine-L 250 mg/mL Injectable vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix Injectable 30 mg/1 mg/25 mcg/mL vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Ultra-test (Cyp 80%/Prop 20%) Injectable, 250 mg/mL vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP 3 mg/3 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP & 9 mg/3.15 mg/3.15 mg Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Inositol/Choline/B-Complex+Leucine+Carn+Chrom+Lido recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC/Chromium/B12(M) Injectable recalled by Wells Pharmacy Network	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin, Lyophilized Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Phenylephrine HCl Injectable, 1 mg/mL (0.1%) vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Glutathione 200 mg/mL Injectable vial recalled by Wells Pharmacy Network	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Methylcobalamin 1,000 mcg/mL Injectable, a) vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Tri 1 (Pap/Phen/Atropine) NR Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin+B12(C) recalled by Wells Pharmacy Network	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Methylcobalamin 5,000 mcg/mL Injectable vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Mitomycin Solution Injectable, Sterile recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin (New York State) Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Mic/B-comp+Lido 20 mg/40 mg/50 mg/10 mg/mL Injectable vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Ultra-test (Cyp 80%/Prop 20%) Injectable, 200 mg/mL vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin, Lyophilized Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Dexamethasone Sodium Phosphate 200 mg/mL, Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Mic/B-comp/(M)/Chrom/Carn, 20 mg/40 mg/50 mg/25 mcg/25 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Propionate Injectable, 100 mg/mL vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	NADH/Carnitine/Taurine/B12(M) Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin, Lyophilized (HCG) Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate 28 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Grapeseed Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate 9 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Nandrolone Decanote (H), 200 mg/mL Injectable vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Grapeseed Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Mic/B-comp+Carn+Lido, 15 mg/30 mg/30 mg/85 mg/20 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate 15 mg Injectable Kit. recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Tri 2 (Pap/Phen/Atropine) NR Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Ultra-test in Grapeseed Oil (Cyp 90%/Prop 10%) Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	QUAD4 (Pap/Phen/Alpros/Atro) 30 mg/3 mg/60 mcg/0.2 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate / Zinc Sulf recalled by Wells Pharmacy Network	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC/Bcomp+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP /Theanine 15 mg/5.4 mg/75 mg recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix Injectable 30 mg/2 mg/40 mcg vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) and vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Dexamethasone Sodium Phosphate 24 mg/mL (2.4%) recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	B-complex + Vit C 20 mg/mL Injectable vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate/Anastrozole Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Arginine HCl 100 mg/mL Injectable recalled by Wells Pharmacy Network	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Chorionic Gonadotropin Lyophilized Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Grapeseed Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP 9 mg/9 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Titan Up (Inos/Chol/Leu/Car/Chro/Lid) Injectable 25 mg/25 recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate/GHRP 6 mg/3 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Bimix 30 mg/1 mg/mL Injectable, a) and b) vial recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Indocyanine Green (P.F.), 15 mg Injectable Kit recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Sesame Oil Injectable, (NY State) recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a), b) recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Methylcobalamin Injectable (Dr. Hall Kit) recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Trimix Injectable 30 mg/3 mg/60 mcg/mL, a), b) and c) vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	QUAD2 (Pap/Phen/Alpros/Atro) 9 mg/1 mg/10 mg/0.1 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Enanthate in Grapeseed Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017	CLASS II	Alprostadil 40 mcg/mL Injectable vials recalled	Wells Pharmacy Network	Sterility	Nationwide

More recalls from Wells Pharmacy Network

All 104

Reported	Class	Recall	Company	Reason	Where
11 Jan 2017Drug	CLASS II	Alprostadil 40 mcg/mL Injectable vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Testosterone Enanthate in Grapeseed Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	QUAD2 (Pap/Phen/Alpros/Atro) 9 mg/1 mg/10 mg/0.1 mg/mL recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Trimix Injectable 30 mg/3 mg/60 mcg/mL, a), b) and c) vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Methylcobalamin Injectable (Dr. Hall Kit) recalled	Wells Pharmacy Network	Sterility	Nationwide

Other Mitomycin recalls

All 24

Reported	Class	Recall	Company	Reason	Where
1 Feb 2023Drug	CLASS II	Mitomycin 0.2mg/ML Droptainer) Oph Solution recalled	Pharmacy Innovations	Sterility	Nationwide
1 Feb 2023Drug	CLASS II	Mitomycin 0.4mg/ML Droptainer) Oph Solution recalled	Pharmacy Innovations	Sterility	Nationwide
18 Jan 2023Drug	CLASS II	Mitomycin Injection Solution, 4mg/ml recalled	Northern VA Compounders Pllc	Sterility	Nationwide
9 Nov 2022Drug	CLASS II	Mitomycin Injection 0.375 mg/mL Syr, 0.375 mg/mL solution syringe recalled	Pharmacy Plus	Sterility	4 states
21 Aug 2019Drug	CLASS II	Mitomycin 10 MG / Ivp Syringe recalled by Infusion Options	Infusion Options	Sterility	NY