FDA recall D-0964-2015

Product

Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England

Reason for recall

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-11-10

Report date

2015-04-29

Termination date

2018-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0964-2015