Recalls / Class III
Class IIID-0329-2021
Product
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
- Brand name
- Candesartan
- Generic name
- Candesartan
- Active ingredient
- Candesartan Cilexetil
- Route
- Oral
- NDCs
- 33342-114, 33342-115, 33342-116, 33342-117
- FDA application
- ANDA203813
- Affected lot / code info
- Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 8015 packs
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-03-22
- FDA classified
- 2021-04-12
- Posted by FDA
- 2021-04-21
- Terminated
- 2022-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0329-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.