Drug recall
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy…
FDA recall event 70831 · Class III · Mylan Pharmaceuticals Inc.
Key facts
| Event ID | 70831 |
|---|---|
| Recall numbers | D-0435-2015 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine. |
| Initiation date | Mar 11, 2015 |
| Report date | Apr 15, 2015 |
| Termination date | Oct 9, 2015 |
| City | Morgantown |
| State | WV |
| Country | United States |
| FEI number | 1110315 |
At a glance
- 1–9 Products in this recall
- 10–99 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: