Why it was recalled
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Product description
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
Lot numbers, UPCs & expiration codes
Lot # B1273286-071521, Exp 07/31/2022
Where it was sold
Product was distributed to two medical facilities in VA and FL.
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-0754-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 17, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 4
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0754-2021, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 88536
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B1273286-071521, Exp 07/31/2022
- Postal code
- 15701-3571
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0754-2021
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 4
- Termination date
- Mar 9, 2022
- Reason for recall
- A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
- Distribution pattern
- Product was distributed to two medical facilities in VA and FL.
- Recall initiation date
- Aug 17, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2021