Why it was recalled
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
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
Lot numbers, UPCs & expiration codes
Lot #: 3051728, 3053762, Exp. 4/2015
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-1083-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 26, 2015
- FDA report date
- May 27, 2015
- Quantity
- 1,363 UD Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-1083-2015, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70857
- Address
- 1718 Northrock Ct
- Code information
- Lot #: 3051728, 3053762, Exp. 4/2015
- Postal code
- 61103-1201
- Report date
- May 27, 2015
- Product type
- Drugs
- Recall number
- D-1083-2015
- Classification
- Class III
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 1,363 UD Cartons
- Termination date
- Aug 31, 2015
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 26, 2015
- Initial firm notification
- Letter
- Center classification date
- May 15, 2015