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RB Issues Voluntary Recall of Liquid Bottles of MUCINEX® FAST-MAX® Night Time Cold & Flu; MUCINEX® FAST-MAX® Cold & Sinus; MUCINEX® FAST-MAX® Severe Congestion & Cough and MUCINEX® FAST-MAX® Cold, Flu & Sore Throat Due to Undeclared Levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine


News provided by

RB

Apr 23, 2015, 10:44 ET

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PARSIPPANY, N.J., April 21, 2015 /PRNewswire/ -- RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of MUCINEX® FAST-MAX® Night Time Cold & Flu; MUCINEX® FAST-MAX® Cold & Sinus; MUCINEX® FAST-MAX® Severe Congestion & Cough and MUCINEX® FAST-MAX® Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This recall was due to a confirmed report from a retailer.

RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of MUCINEX(R) FAST-MAX(R) Night Time Cold & Flu; MUCINEX(R) FAST-MAX(R) Cold & Sinus; MUCINEX(R) FAST-MAX(R) Severe Congestion & Cough and MUCINEX(R) FAST-MAX(R) Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back.
RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of MUCINEX(R) FAST-MAX(R) Night Time Cold & Flu; MUCINEX(R) FAST-MAX(R) Cold & Sinus; MUCINEX(R) FAST-MAX(R) Severe Congestion & Cough and MUCINEX(R) FAST-MAX(R) Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back.

This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients which include Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine.  The voluntary recall is being issued nationwide as a precautionary measure to ensure our consumers have all relevant facts and warnings for the active ingredients contained in the bottle.

Consumers could take a product with undeclared levels of Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine. Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment, taking three or more alcoholic drinks or when taking other medicines containing this active ingredient without consulting a doctor.

RB is notifying its distributors and customers by direct correspondence. As a precautionary measure, RB is asking consumers to responsibly dispose of any unused product in accordance with the following recommended guidance for drug disposal in your household trash:

  • Mix liquid medicines with an unpalatable substance such as kitty litter or used coffee grounds;
  • Place the mixture in a container such as a sealed plastic bag; and
  • Throw the container in your household trash. Consumers who have purchased this product can also contact the RB MUCINEX FAST-MAX recall toll free number at 1-888-943-4215 between the hours of 8:00 a.m.- 8:00 p.m eastern standard time with any questions or to speak with a representative, and should refer to our website, www.mucinex.com/recall for the accurate related drug facts information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

MUCINEX FAST-MAX Night-Time Cold & Flu Liq

AA037

12/31/2016

AA060

1/31/2017

AA080

1/31/2017

AA097

1/31/2017

MNT0003

7/31/2016

MNT0004

7/31/2016

MNT0005

7/31/2016

MNT0006

7/31/2016

MNT0007

7/31/2016

MNT0008

7/31/2016

MNT0009

7/31/2016

MNT0010

7/31/2016

MNT0011

7/31/2016

MNT0012

7/31/2016

MNT0013

7/31/2016

MNT0014

10/31/2016

MNT0015

10/31/2016

MNT0016

10/31/2016

MNT0016

10/31/2016

MNT0017

10/31/2016

MNT0018

11/30/2016

MNT0019

11/30/2016

MNT0020

12/31/2016

MNT0021

12/31/2016

MNT0022

12/31/2016

MNT0023

12/31/2016

MNT0024

12/31/2016

MNT0025

12/31/2016




MUCINEX FAST-MAX Cold & Sinus Liquid

MCS0019

7/31/2016

MCS0020

7/31/2016

MCS0021

7/31/2016

MCS0022

8/31/2016

MCS0023

8/31/2016

MCS0024

9/30/2016

MCS0025

9/30/2016

MCS0026

9/30/2016

MCS0027

11/30/2016

MCS0028

10/31/2016

MCS0029

10/31/2016

MCS0030

12/31/2016

MCS0031

12/31/2016

MCS0032

12/31/2016

MCS0033

12/31/2016




MUCINEX FAST-MAX Severe Congestion & Cough Liq

MSC0049

8/31/2016

MSC0050

8/31/2016

MSC0051

8/31/2016

MSC0052

8/31/2016

MSC0053

8/31/2016

MSC0054

8/31/2016

MSC0055

8/31/2016

MSC0056

9/30/2016

MSC0057

9/30/2016

MSC0058

9/30/2016

MSC0059

10/31/2016

MSC0060

10/31/2016

MSC0061

10/31/2016

MSC0062

10/31/2016

MSC0063

10/31/2016

MSC0064

10/31/2016

MSC0065

10/31/2016

MSC0066

10/30/2016

MSC0067

11/30/2016

MSC0068

11/30/2016

MSC0069

11/30/2016

MSC0070

11/30/2016

MSC0071

11/30/2016

MSC0072

11/30/2016

MSC0073

11/30/2016

MSC0074

11/30/2016

MSC0075

11/30/2016

MSC0076

11/30/2016

MSC0077

12/31/2016

MSC0078

12/31/2016

MSC0079

12/31/2016

MSC0080

12/31/2016

MSC0082

12/31/2016




MUCINEX FAST-MAX Cold,Flu & Sore Throat Liq

MCF0048

7/31/2016

MCF0051

7/31/2016

MCF0052

8/31/2016

MCF0053

8/31/2016

MCF0054

8/31/2016

MCF0055

8/1/2016

MCF0056

8/31/2016

MCF0057

8/31/2016

MCF0058

8/31/2016

MCF0059

10/1/2016

MCF0060

8/31/2016

MCF0061

8/31/2016

MCF0062

8/31/2016

MCF0063

9/30/2016

MCF0064

9/30/2016

MCF0065

9/30/2016

MCF0066

9/30/2016

MCF0067

9/30/2016

MCF0068

9/30/2016

MCF0069

10/1/2016

MCF0070

10/31/2016

MCF0071

10/31/2016

MCF0072

10/31/2016

MCF0073

10/31/2016

MCF0074

10/31/2016

MCF0075

10/31/2016

MCF0076

10/31/2016

MCF0077

10/31/2016




MUCINEX FAST-MAX  Liquid combination - Day Night Severe Cold and Night-Time Cold & Flu.

WO00706571

7/31/2016

WO00707442

7/31/2016

WO00707443

7/31/2016

WO00707444

7/31/2016

WO00707822

7/31/2016

WO00709953

7/31/2016

WO00709955

6/30/2016

WO00720780

7/31/2016

WO00721052

7/31/2016

WO00721170

7/31/2016

WO00721171

7/31/2016

WO00726864

6/30/2016

WO00726865

7/31/2016

WO00728864

12/31/2016

WO00728865

12/31/2016

WO00728866

12/31/2016

WO00730003

12/31/2016

WO00730004

12/31/2016

WO00735142

12/31/2016

WO00736753

12/31/2016

WO00737477

1/31/2017

WO00737979

1/31/2017

WO00738556

12/31/2016

WO00739050

12/31/2016

WO00740405

1/31/2017

WO00740406

1/31/2017




MUCINEX FAST-MAX  Liquid combination packs - Daytime Severe Congestion & Cough Night-Time Cold & Flu

WO00707825

5/31/2016

WO00713226

7/31/2016

WO00715310

6/30/2016

WO00715505

7/31/2016

WO00721174

9/30/2016

WO00721177

10/31/2016

WO00726860

10/31/2016

WO00726862

6/30/2016

WO00726952

8/31/2016

WO00728861

6/30/2016

WO00728878

7/31/2016

WO00728879

9/30/2016

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Photo - http://photos.prnewswire.com/prnh/20150421/200185

Consumer Contact:
1-888-943-4215

SOURCE RB

Related Links

http://www.mucinex.com

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