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
FDA recall notice · announced April 29, 2015 · Reckitt Benckiser
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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
Notes
Distribution: Nationwide
Lot/code information: Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016
Quantity: 155 cases (2000 pouches of 2 tablets per case)
Status: Terminated
Products in this recall event:
- 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 (D-0964-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.