Fexofenadine Hydrochloride Tablets recall: Impurity Out of Spec
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan…
Why was Fexofenadine Hydrochloride Tablets recalled?
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
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 #: 3051728, 3053762, Exp. 4/2015
- Product
- Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan…
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Quantity
- 1,363 UD Cartons
- Distribution
- Nationwide
- Recall date
- May 27, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)