The Recall Desk
HighFDA (Devices)·Z-1640-2015·Announced 2015-05-27

Richard-Allan Scientific Recalls Mucolexx Mucolytic Agent Due to Fungal Contamination

Richard-Allan Scientific is recalling Mucolexx mucolytic agent and Mucolexx products after a customer reported fungal contamination in two lots.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (fungal contamination) in a medical device without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Richard-Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx products. The recall was initiated following a customer complaint reporting that a laboratory had found fungal contamination in two lots of Mucolexx.

The affected products include Lerner Laboratories Mucolexx (1 pint / 473 ml & 1 gallon/3.8 L) and Shandon Mucolexx (500ml/0.13gal, 4L/1.06 gal, 120mL). These products are mucoliquefying preservatives designed for use in the preparation of mucoid cytology specimens. The recall covers 506 cases distributed across various product codes and lot numbers.

The products were distributed worldwide, including nationwide in the United States and in numerous international countries. Users of these products should stop using them and contact Richard-Allan Scientific for further instructions.

The recalled product

Product
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus an
Manufacturer
Richard-Allan Scientific Company
Category
Medical Device — Laboratory Reagent
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lerner Laboratories Mucolexx
  • 272123-Sep-2015
  • 317218-Dec-2016
  • 266312-Jul-2015. Shandon Mucolexx 500ml/0.13gal
  • 4L/1.06 gal
  • 120mL
  • Product Code 9990370
  • 9990371 & 9990375
  • Lot Numbers & EXP Dates: 328311-Mar-2017
  • 324252-Feb-2017
  • 314543-Dec-2016
  • 304548-Jul-2016
  • 289566-Mar-2016
  • 282598-Dec-2015
  • 276182-Nov-2015
  • 267432-Aug-2015
  • 255776-Apr-2015
  • 311289-Oct-2016
  • 299148-Jun-2016
  • 285035-Feb-2016

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Richard-Allan Scientific Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · fungal contamination

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