Reported Apr 15, 2015 · Terminated
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original…
Mylan Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- 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 byMylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA
- Lot codes and dates
Lot #: 3047303Exp 04/2015
- Amount recalled
- 13,856 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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