Recalls / Class III
Class IIID-0049-2021
Product
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.
- Brand name
- Candesartan Cilexetil And Hydrochlorothiazide
- Generic name
- Candesartan Cilexetil And Hydrochlorothiazide
- Active ingredients
- Candesartan Cilexetil, Hydrochlorothiazide
- Route
- Oral
- NDCs
- 0378-3001, 0378-3002, 0378-3003
- FDA application
- ANDA090704
- Affected lot / code info
- Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
Why it was recalled
Out-of-specification organic impurity results obtained during routine stability testing.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 10,695 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-10-02
- FDA classified
- 2020-10-22
- Posted by FDA
- 2020-10-28
- Terminated
- 2022-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0049-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.