CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

TB Potassium Permanganate (.5% Aqueous) recalled by Remel

Remel is recalling Remel TB Potassium Permanganate (.5% Aqueous) 40192, distributed nationwide in the US. The recall was initiated on 29 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 293086 Expiration 01Apr2015

Quantity recalled79/5/250- packages/bottles/ml

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0449-2015
FDA event ID: 69629
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Terminated
Recall initiated: 29 Oct 2014
FDA classified: 24 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

29 Oct 2014	Recall initiated by company
24 Nov 2014	Classified by FDA	+26 days
3 Dec 2014	Published in enforcement report	+9 days

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

Reason for recall

The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

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

Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

Where it was distributed

Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.

Nationwide Alabama California Colorado Iowa Missouri North Carolina Nevada New York Ohio Pennsylvania South Carolina South Dakota Tennessee Texas Virginia Wisconsin

Questions about this recall

Is TB Potassium Permanganate (.5% Aqueous) 40192 recalled?

Yes. Remel recalled TB Potassium Permanganate (.5% Aqueous) 40192 on 29 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0449-2015.

Why was it recalled?

The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

Which lots are affected?

Lot: 293086 Expiration 01Apr2015

Where was it sold?

Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

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

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