Why it was recalled
Failed Impurities/Degradation Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.
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-0329-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 22, 2021
- FDA report date
- Apr 21, 2021
- Quantity
- 8015 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0329-2021, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87607
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.
- Postal code
- 08536-0009
- Report date
- Apr 21, 2021
- Product type
- Drugs
- Recall number
- D-0329-2021
- Classification
- Class III
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 8015 packs
- Termination date
- Dec 13, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 22, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2021