Mylan Pharmaceuticals Inc. recalls Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescr…
- Recall date
- March 11, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0435-2015
- FDA classification
- Class III
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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