Why it was recalled
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Product description
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Lot numbers, UPCs & expiration codes
Z006279, exp 12/31/2022
Where it was sold
Nationwide in the US
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-0753-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 2880 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0753-2021, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88482
- Address
- 73 Route 31 N
- Code information
- Z006279, exp 12/31/2022
- Postal code
- 08534-3601
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0753-2021
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 2880 bottles
- Termination date
- Apr 3, 2023
- Reason for recall
- Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Aug 13, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2021