D-0435-2015 Class III Terminated
FDA drug recall D-0435-2015 was initiated by Mylan Pharmaceuticals Inc. on Mar 11, 2015 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine. The recall status is terminated (terminated Oct 9, 2015). Affected quantity: 13,856 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 15, 2015
- Initiation Date
- Mar 11, 2015
- Termination Date
- Oct 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,856 Bottles
Product description
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.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Distribution pattern
Nationwide
Code information
Lot #: 3047303, Exp 04/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0435-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026