Reported May 27, 2015 · Terminated
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD…
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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 Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201
Is this the product you have?
- Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons
- Manufactured byMylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
- Lot codes and dates
Lot #: 30517283053762Exp. 4/2015
- Amount recalled
- 1,363 UD Cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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