Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Lot numbers, UPCs & expiration codes
Lot #: AVF0256/A , AVF0256/B, AVF0256/C; Exp. 02/17
Where it was sold
Nationwide
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-1506-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 27, 2016
- FDA report date
- Sep 28, 2016
- Quantity
- 612 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-1506-2016, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74694
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: AVF0256/A , AVF0256/B, AVF0256/C; Exp. 02/17
- Postal code
- 08512-3605
- Report date
- Sep 28, 2016
- Product type
- Drugs
- Recall number
- D-1506-2016
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 612 HDPE bottles
- Termination date
- Mar 26, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2016