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.
Reported: April 15, 2015 Initiated: March 11, 2015 #D-0435-2015
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 13,856 Bottles
- Distribution
- Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 13,856 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 15, 2015. Severity: Low. Recall number: D-0435-2015.
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