Inspections, Compliance, Enforcement, and Criminal Investigations

January 3, 2017: Notification of Stolen Reckitt Benckiser Retail, Non-Prescription, Consumer Healthcare Products

FDA posts press releases and other notices from firms as a service to consumers, the media, and other interested parties.

 

Reckitt Benckiser is working with the U.S. Food and Drug Administration (FDA), Office of Criminal Investigation (OCI), and other law enforcement officials to recover cases of select lots of retail, non-prescription, consumer healthcare products. The trailers containing the products were both stolen while en route to a Reckitt Benckiser Distribution Center in Springfield, Missouri on the 7th and 10th of October, 2016. The trailers were both taken from a warehouse in Edison, New Jersey. The stolen trailers contained multiple products and partial lots of Reckitt Benckiser healthcare products, including Maximum Strength Mucinex® Sinus-Max® Day & Night, Cepacol Maximum Strength Throat and Cough Drop Lozenges Mixed Berry, Mucinex® Fast-Max® Night Time Cold & Flu, and Delsym Adult Night Time Cough and Cold Liquid.

 

Potentially impacted lots are listed in Table 1 below.

All Mucinex®, Cepacol® and Delsym® products are safe and effective when used as directed and purchased from legitimate and reputable retail outlets and pharmacies. Reckitt Benckiser recommends that consumers always inspect the product and label for signs of tampering before opening. Mucinex®, Cepacol® and Delsym® products are packaged in "tamper-evident" containers, meaning that if the package has been opened, it will be evident to the consumers. In addition, consumers and retailers should report any evidence of suspected product tampering to our toll-free number 866-682-4639.

Reckitt Benckiser advises consumers and retailers to always purchase product only from trusted and reliable sources. For consumer inquiries about a specific product, please call the toll-free number (866-682-4639) identified on the package.

Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for the specified Reckitt Benckiser products after the date of the theft, is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or to visit the OCI Web Site (http://www.fda.gov/OCI).

Below is the list of affected products, including Item number, Description/Size, Lot Code and Lot expiration.

 

NAME

LOT #

EXPIRATION

ITEM #

DOSAGE FORM

INGREDIENTS

MUCINEX SINUS-MAX D/N 24/20CT

CA554

7/2018

63824-20220-04

Caplet

Per Caplet:

 

Day: APAP 325mg, GGE 200mg, PE HCl 5mg

 

Night: APAP 325mg, PE HCl 5mg, DPH 12.5mg

 

CEPACOL LOZ MIX BERRY 24/16CT

CA804

8/2018

63824-74016-06

Lozenges

In each lozenge:

 

Benzocaine 7.5mg, Dextromethorphan hydrobromide 5mg

MUCINEX NIGHT C&F 6/6Z

6239E2

8/2018

63824-50066-00

Liquid

In each 20 mL:

 

APAP 650mg, DPH 25mg, PE HCl 10mg

 

DELSYM ADULT DM 6/6OZ

 6250E1

9/2018

63824-21366-00

Liquid Suspension

In each 20 mL:

 

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

 Reckitt Benckiser has taken quick and appropriate actions to ensure the safety of their products and will continue to work closely with law enforcement, the FDA, and distribution partners to maintain the integrity of the supply chain.

 

 

Page Last Updated: 01/29/2018
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