D-0964-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2015
- Initiation Date
- November 10, 2014
- Termination Date
- March 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 155 cases (2000 pouches of 2 tablets per case)
Product Description
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 Pattern
Nationwide
Code Information
Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016