FDA Drug Class III — Least Serious

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

Hazard

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

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Products

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 07054-022
Brand
Reckitt Benckiser LLC
UPC
Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016

Units Affected

155 cases (2000 pouches of 2 tablets per case)

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