CLASS II Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report

Pyridoxine HCL 100 mg/mL NS (PF), Medaus Pharmacy 1 recalled

Medaus is recalling Pyridoxine HCL 100 mg/mL NS (PF), Medaus Pharmacy 1-800-526-9183, distributed nationwide in the US. The recall was initiated on 23 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT # 130531-31, Exp 11/27/2013

Quantity recalled2970 mL

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-1052-2013
FDA event ID: 66172
Recalling firm: Medaus, Birmingham, AL
Classification: Class II
Status: Terminated
Recall initiated: 23 Aug 2013
FDA classified: 13 Sep 2013
Reported: 25 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility

Timeline

23 Aug 2013	Recall initiated by company
13 Sep 2013	Classified by FDA	+21 days
25 Sep 2013	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: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

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 HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

LOT # 130531-31, Exp 11/27/2013

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

7 other products · FDA event 66172

This product is part of a recall event; the main page for the event is Magnesium Chl 200 mg/mL PF, Medaus Pharmacy 1 recalled.

Reported	Class	Recall	Company	Reason	Where
25 Sep 2013	CLASS II	Magnesium Chl 200 mg/mL PF, Medaus Pharmacy 1 recalled	Medaus	Sterility	Nationwide
25 Sep 2013	CLASS II	Taurine 50 mg/mL PF, Medaus Pharmacy 1 recalled	Medaus	Sterility	Nationwide
25 Sep 2013	CLASS II	L-Glutathione 200 mg/mL PF, Medaus Pharmacy 1 recalled	Medaus	Sterility	Nationwide
25 Sep 2013	CLASS II	NA Ascorbate 500 mg/mL, PF, Medaus Pharmacy 1 recalled	Medaus	Sterility	Nationwide
25 Sep 2013	CLASS II	Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg recalled by Medaus	Medaus	Sterility	Nationwide
25 Sep 2013	CLASS II	Testosterone Cyp 200 mg/mL, W/Pres recalled by Medaus	Medaus	Sterility	Nationwide
25 Sep 2013	CLASS II	NA Ascorbate 500 mg/mL, non corn PF, Medaus Pharmacy, 1 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 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
11 Mar 2020Drug	CLASS II	Pyridoxine Hydrochloride Injection recalled by Fusion IV Pharmaceuticals	Fusion IV Pharmaceuticals	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