Drug recall
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24…
FDA recall event 63821 · Class III · Bayer Healthcare, LLC
Key facts
| Event ID | 63821 |
|---|---|
| Recall numbers | D-177-2013 |
| Recalling firm | Bayer Healthcare, LLC |
| Product type | Drugs |
| Products | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label. |
| Initiation date | Dec 7, 2012 |
| Report date | Mar 6, 2013 |
| Termination date | Apr 1, 2014 |
| City | Morristown |
| State | NJ |
| Country | United States |
| FEI number | 3000206585 |
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: