Drug recall
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per…
FDA recall event 70840 · Class III · Reckitt Benckiser LLC
Key facts
| Event ID | 70840 |
|---|---|
| Recall numbers | D-0964-2015 |
| Recalling firm | Reckitt Benckiser LLC |
| Product type | Drugs |
| 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch |
| Initiation date | Nov 10, 2014 |
| Report date | Apr 29, 2015 |
| Termination date | Mar 30, 2018 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3011015568 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: