Why it was recalled
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Product description
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Lot numbers, UPCs & expiration codes
Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19
Where it was sold
Nationwide in the USA
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-0428-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 18, 2019
- FDA report date
- Feb 6, 2019
- Quantity
- 88,090 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0428-2019, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 81930
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19
- Postal code
- 26505-2730
- Report date
- Feb 6, 2019
- Product type
- Drugs
- Recall number
- D-0428-2019
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 88,090 bottles
- Termination date
- Oct 9, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2019