FDAClass IIIApril 15, 2015

Fexofenadine HCl Tablets recall: Impurity Out of Spec

Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count…

Why was Fexofenadine HCl Tablets recalled?

Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 3047303, Exp 04/2015

Product
Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count…
Recalling firm
Mylan Pharmaceuticals Inc.
Quantity
13,856 Bottles
Distribution
Nationwide
Recall date
April 15, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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