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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Richard-Allan Scientific Company
- 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
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 →Related recalls
Same manufacturer · Richard-Allan Scientific Company
See all →- LowRichard-Allan Scientific Recalls Mislabeled EZ Single Cytofunnel Brown Units
FDA (Devices) · 2018-08-22
- ModerateRichard-Allan Scientific Recalls Shandon Rapid Chrome Kwik-Diff Kits
FDA (Devices) · 2017-05-10
- SevereRichard Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Contamination
FDA (Devices) · 2016-08-17
- LowRichard-Allan Scientific Recalls Type 3 Paraffin Due to Mislabeling
FDA (Devices) · 2016-04-13
- HighRichard Allan Scientific Recalls Mucolytic Agent Due to Fungal Contamination
FDA (Devices) · 2015-05-27
Same hazard · fungal contamination
See all →- CriticalMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- CriticalMedline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
FDA (Devices) · 2026-09-23
Similar recalls
- SevereRichard Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Contamination
FDA (Devices) · 2016-08-17
- SevereFranck's Lab Recalls Moxifloxacin Injectable Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereKing Bio Recalls Dr. King's SafeCare Rx Allergies: Mold for Microbial Contamination
FDA (Drugs) · 2019-03-20
- SevereFranck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Lidocaine Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereAntacid Medication Recalled Nationwide for Microbial Contamination Risk
FDA (Drugs) · 2022-09-14