CLASS II Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report

Methyl B12 10MG/ML W/Pres (Benzalkonium 0.01%) IN Nacl recalled

Medaus is recalling Methyl B12 10MG/ML W/Pres (Benzalkonium 0.01%) IN Nacl 0.9%, In a) Vials, b) Vials, and, distributed nationwide in the US. The recall was initiated on 13 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Lot #: 160201-11, BUD: 07/11/16; Lot #: 160215-13, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. b) Lot #: 160315-1, BUD: 07/11/16; Lot #: 160201-11, BUD: 07/11/16; Lot #: 160210-71, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. c) Lot #: 160125-17, BUD: 07/11/16; Lot #: 160210-35, BUD: 07/11/16; Lot #: 160222-20, BUD: 07/11/16; Lot #: 160204-46, BUD: 07/11/16; Lot #: 160307-25, BUD: 07/11/16.

Quantity recalled331 mL in Vials

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-1219-2016
FDA event ID: 74466
Recalling firm: Medaus, Birmingham, AL
Classification: Class II
Status: Terminated
Recall initiated: 13 May 2016
FDA classified: 8 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

13 May 2016	Recall initiated by company
8 Jul 2016	Classified by FDA	+56 days
20 Jul 2016	Published in enforcement report	+12 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

METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

Where it was distributed

U.S. Nationwide, Japan, and New Zealand.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

a) Lot #: 160201-11, BUD: 07/11/16; Lot #: 160215-13, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. b) Lot #: 160315-1, BUD: 07/11/16; Lot #: 160201-11, BUD: 07/11/16; Lot #: 160210-71, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. c) Lot #: 160125-17, BUD: 07/11/16; Lot #: 160210-35, BUD: 07/11/16; Lot #: 160222-20, BUD: 07/11/16; Lot #: 160204-46, BUD: 07/11/16; Lot #: 160307-25, BUD: 07/11/16.

Where was it sold?

U.S. Nationwide, Japan, and New Zealand.

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

87 other products · FDA event 74466

This product is part of a recall event; the main page for the event is M.i.c B-complex Premix W/hydroxy B12 W/pres recalled by Medaus.

Reported	Class	Recall	Company	Reason	Where
20 Jul 2016	CLASS II	M.i.c B-complex Premix W/hydroxy B12 W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	M.i.c 25/50/50 W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Dexpanthenol 250mg/ML W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	L-glutathione 100MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Methyl B12 10MG/ML (PF) IN Nacl 0.9% Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	L-carnitine 500MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Magnesium Chl 200MG/ML (PF), In a) Vials and b) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Methyl B12 1000MCG/ML IN Nacl 0.9% (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo-injection W/lidocaine W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex Nacl 0.9% W/pres., (benzyl Etoh 2%), B1-50mg recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Minoxidil 0.5% W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Pyridoxal 50 MG/Thiamine 50 MG/Lidocaine 1% NS (PF) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Arginine 100MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Manganese SO4 0.1MG/ML (PF), In a) 2MLVials and b) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo #4 W/methyl B12 500 MCG/ML/no Methionine W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Folic Acid 10mg/ML W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydroxy B12 5MG/ML IN Nacl 0.9% (PF), In a) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydroxy B12 1000MCG/ML IN Nacl 0.9% (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo-boost W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS III	Pyridoxine HCL 100MG/ML W/Pres (Benzyl Etoh 0.02%) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Nandrolone Dec 200mg/ML W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydroxy B12 5MG/ML W/Pres (Benzalkonium 0.01%) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Edta Disodium 15% (150MG/ML) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	HCL 2MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex #3 W/pres (benzyl Etoh 2%), B1-100mg recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo W/lidocaine #3 W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	M.I.C. 25/50/50 (PF) Methionine 25MG;Inositol 50MG;Choline recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Thiamine 100 MG/ML Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lidocaine 2% (PF) IN Nacl Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Dmso 99.9 (PF), In a) Vials and b) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Testosterone Cyp 20 MG/ML W/Pres (Benzyl Etoh 2%) recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Pyridoxine HCL 100MG/ML (PF), In a) Vials and b) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex Without B12 (pf) In Nacl 0.9%, B1-100mg recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Dmps 50MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Molybdenum 250MCG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo-injection W/methyl B12 1 MG/ML W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Taurine 50 MG/ML (PF), In a) Vials, b) Vials, and c) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	L-phenylalanine 15MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	L-carnitine 100MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Zinc SO4 10MG/ML (PF), Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydroxy B12 1000MCG/ML W/Pres (Benzalkonium 0.01%) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Hyaluronidase 500U/ML(PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo-injection W/methyl B12 500 MCG/carnitine/no Vit C W/pres recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Gaba 50MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo-injection W/methyl B12 500 MCG/ML W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Tmg 100 MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Zinc Chloride 10MG/ML IN Nacl 0.29% (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Riboflavin 10MG/ML (PF), In a) Vials and b) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Taurine 50 MG/ML W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	L-carnitine 250MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Testosterone Cyp 100 MG/ML W/Pres (Benzyl Etoh 2%) recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Methyl B12 1000MCG/ML W/Pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydrogen Peroxide 3% (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	M.i.c./b-complex (pf) B1-50mg;b2-5-po4-5mg;b3-50mg;b6-5mg recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Germanium Seso 100MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	M.I.C 25/50/50 W/Methyl B12 1MG/Pyridoxal 50MG/ML recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Folic Acid 10MG/ML IN Nacl (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo-injection W/lidocaine (pf), Ascorbic Acid 50mg recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Niacinamide 100 MG/ML (PF), In a) Vials, b) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo-injection W/lidocaine No Methionine W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Dexpanthenol 250MG/ML (PF), In a) Vials and b) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Selenium 200MCG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Proline 100MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Cesium Chloride 600MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Tryptophan 10MG/ML (PF), In a) Vials and b) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	NA Ascorbate 500MG/ML (PF), In a) Vials, b) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	L-carnitine 50MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Methyl B12 1000mcg/ML/pyridoxine 100mg W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Testosterone Cyp 25 MG/ML W/Pres (Benzyl Etoh 2%) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex W/methyl B12/lido W/pres (benzyl Etoh 2%) recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	M.i.c B-complex W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	NA Ascorbate 500MG/ML Non-corn (PF), In a) Vials, b) Vials recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Lipo B Cyano 1mg/ML W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Zinc SO4 1MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex (lieberman) In Nacl 0.9% (pf), B1-12.5mg recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex Without B12 W/pres (benzyl Etoh 2%), B1-100mg recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex W/cyano B12 W/pres., (benzyl Etoh 2%), B1-100mg recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Testosterone Cyp 200 MG/ML W/Pres (Benzyl Etoh 2%) recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Methyl B12 5MG/ML (PF) IN Nacl 0.9% Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Calcium Sodium Edta 300MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Testosterone Cyp 50 MG/ML W/Pres (Benzyl Etoh 2%) recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Procaine 2% (PF), In a) Vials and b) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Estradiolval 3mg/test Cyp 35mg/ Test Prop 35mg/ML W/pres recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Thiamine 100 MG/ML W/Pres (Benzalkonium 0.01%) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	B-complex Nacl 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG recalled	Medaus	Sterility	Nationwide
20 Jul 2016	CLASS II	Manganese Chl 0.1MG/ML PF Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide

More recalls from Medaus

All 96

Reported	Class	Recall	Company	Reason	Where
20 Jul 2016Drug	CLASS II	Manganese Chl 0.1MG/ML PF Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	B-complex Nacl 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG recalled	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Thiamine 100 MG/ML W/Pres (Benzalkonium 0.01%) Vials recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Estradiolval 3mg/test Cyp 35mg/ Test Prop 35mg/ML W/pres recalled	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Procaine 2% (PF), In a) Vials and b) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide

Other Methyl B12 recalls

All 8

Reported	Class	Recall	Company	Reason	Where
20 Jul 2016Drug	CLASS II	Methyl B12 5MG/ML (PF) IN Nacl 0.9% Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Methyl B12 1000mcg/ML/pyridoxine 100mg W/pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Methyl B12 1000MCG/ML W/Pres recalled by Medaus	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Methyl B12 1000MCG/ML IN Nacl 0.9% (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Methyl B12 10MG/ML (PF) IN Nacl 0.9% Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide