Why it was recalled
Out-of-specification organic impurity results obtained during routine stability testing.
Product description
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Lot numbers, UPCs & expiration codes
Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
Where it was sold
Nationwide within the United States
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-0049-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 2, 2020
- FDA report date
- Oct 28, 2020
- Quantity
- 10,695 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0049-2021, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 86520
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
- Postal code
- 26505-2730
- Report date
- Oct 28, 2020
- Product type
- Drugs
- Recall number
- D-0049-2021
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 10,695 bottles
- Termination date
- Jan 24, 2022
- Reason for recall
- Out-of-specification organic impurity results obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 22, 2020