FDA Device recall Z-1640-2015
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L by Richard Allan Scientific, citing richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1640-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-29 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Richard Allan Scientific |
| Distribution | US |
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 and allows for optimal cytologic diagnostic results.
Reason
Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx.
Identifiers
| code_info | Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L-Product Codes 44041& 44042. Lot Numbers & EXP Dates: 30…Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L-Product Codes 44041& 44042. Lot Numbers & EXP Dates: 301362-Jun-2016; 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; 273852-Oct-2015; 263847-Jul-2015; 312363-Oct-2016 & 255325-Apr-2015 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1640-2015%22
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