Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Product description
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Lot numbers, UPCs & expiration codes
Lot #: Z803518, Exp 08/2020
Where it was sold
Nationwide in the USA
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-1242-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 22, 2019
- FDA report date
- May 1, 2019
- Quantity
- 7668 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1242-2019, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82682
- Address
- 73 Route 31 N
- Code information
- Lot #: Z803518, Exp 08/2020
- Postal code
- 08534-3601
- Report date
- May 1, 2019
- Product type
- Drugs
- Recall number
- D-1242-2019
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 7668 bottles
- Termination date
- Jan 14, 2021
- Reason for recall
- Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2019