Mucinex DM Recalled for Defective Pouch Seal
Reckitt Benckiser is recalling Mucinex DM extended-release tablets due to a defective seal on the top of the pouch.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging defect (defective seal) rather than a contamination or labeling error affecting the drug substance itself.
Plain-English summary
Reckitt Benckiser LLC is recalling Mucinex DM (guaifenesin and dextromethorphan hydrobromide) extended-release bi-layer tablets. The recall was initiated after a customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch.
The affected product is Mucinex DM, NDC 63824-056-72, which contains 2 tablets per pouch. The recall covers 155 cases, totaling 2,000 pouches. The specific lots involved are BD375 (exp 06/2016), BD566 (exp 08/2016), and BD661 (exp 08/2016). The product was distributed nationwide.
Consumers with this product should check their lot numbers and expiration dates. If they have the affected product, they should stop using it and contact Reckitt Benckiser for a refund or replacement.
The recalled product
- Product
- MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE)
- Brand
- MUCINEX DM
- Manufacturer
- Reckitt Benckiser LLC
- Category
- Drug — OTC Cough and Cold
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot BD375 exp 06/2016
- BD566
- BD661 exp. 08/2016
UPCs (1)
- 0363824056203
Distribution
Distributed nationwide across the United States.
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