Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the prepa

FDA device recall Z-1639-2015 · posted 2015-05-21 · Terminated

Recall details

Recalling firm

Richard-Allan Scientific Company

Reason for recall

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.

Action taken

Richard Allan Scientific (RAS) initiated a voluntary recall of Mucolexx and Mucolytic Agent due to fungal contamination on 5/1/2015 via certified mail to all customers who received the affected. Customers were asked to return a repsonse form, and dispose or return all recalled products. Please contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher

Root cause

Material/Component Contamination

Status

Terminated

Product code

LEA

Quantity affected

Product 76166- 116; Product Code 76167-29

Distribution

Worldwide Distribution - US Nationwide in the states of: AR; AZ; CA; CO; FL; GA; I A; IL; IN; KY; MA; MN; MO; MS; MT; NC; ND; NJ; NV; NY; OH; OK; PA; PR; SD; TN; TX; VA; WA; WI and the countries of: B

Date initiated

2015-04-29

Date posted

2015-05-21

Date terminated

2016-03-09

Location

Kalamazoo, MI