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 #: 3051728
    • 3053762
    • Exp. 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 31, 2015 · Data as of Sep 19, 6:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.