Drug 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
D-0964-2015
Product summary
- Event
- Event 70840
- Status
- Terminated
- Classification
- Class III
- Quantity
- 155 cases (2000 pouches of 2 tablets per case)
- Official record key
drug-enforcement:D-0964-2015
Official wording
Reason: Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Code information: Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
defective seal