Why it was recalled
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Product description
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Lot numbers, UPCs & expiration codes
Lot # 3107334, exp. date October 2021
Where it was sold
Product was distributed 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-0798-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 13, 2021
- FDA report date
- Sep 22, 2021
- Quantity
- 21,094
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris
Original FDA data
Every field from FDA enforcement report D-0798-2021, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 88609
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot # 3107334, exp. date October 2021
- Postal code
- 26505-2730
- Report date
- Sep 22, 2021
- Product type
- Drugs
- Recall number
- D-0798-2021
- Classification
- Class III
- Recalling firm
- Viatris
- Product quantity
- 21,094
- Termination date
- Apr 28, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications; out of specification for Related Compound
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Sep 13, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 14, 2021