Recalls / Class III
Class IIID-0798-2021
Product
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
- Brand name
- Candesartan Cilexetil
- Generic name
- Candesartan Cilexetil
- Active ingredient
- Candesartan Cilexetil
- Route
- Oral
- NDCs
- 0378-3224, 0378-3225, 0378-3231, 0378-3232
- FDA application
- ANDA078702
- Affected lot / code info
- Lot # 3107334, exp. date October 2021
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Recalling firm
- Firm
- Viatris
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 21,094
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-09-13
- FDA classified
- 2021-09-14
- Posted by FDA
- 2021-09-22
- Terminated
- 2022-04-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0798-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.