Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
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.
Lot numbers, UPCs & expiration codes
Lot #: 3047303, Exp 04/2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0435-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 11, 2015
- FDA report date
- Apr 15, 2015
- Quantity
- 13,856 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0435-2015, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 70831
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: 3047303, Exp 04/2015
- Postal code
- 26505-2730
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-0435-2015
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 13,856 Bottles
- Termination date
- Oct 9, 2015
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 11, 2015
- Initial firm notification
- Center classification date
- Apr 7, 2015