FDAFDA · Food and drugs·Recall number D-0435-2015
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 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.
Published April 15, 2015 · Recall initiated: March 11, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- Lot #: 3047303, Exp 04/2015
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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