D-1083-2015 Class III Terminated
FDA drug recall D-1083-2015 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on Mar 26, 2015 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing The recall status is terminated (terminated Aug 31, 2015). Affected quantity: 1,363 UD Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 27, 2015
- Initiation Date
- Mar 26, 2015
- Termination Date
- Aug 31, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,363 UD Cartons
Product Description
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
Reason for Recall
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Distribution Pattern
Nationwide
Code Information
Lot #: 3051728, 3053762, Exp. 4/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1083-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026