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
Reported: May 27, 2015 Initiated: March 26, 2015 #D-1083-2015
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
Details
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- 1,363 UD Cartons
- Distribution
- Nationwide
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 1,363 UD Cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 27, 2015. Severity: Low. Recall number: D-1083-2015.
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