Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Product description
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Lot numbers, UPCs & expiration codes
Lot #: MP4967, Expiry: 04/2016.
Where it was sold
US Nationwide including Puerto Rico
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-0725-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 14, 2016
- FDA report date
- Mar 2, 2016
- Quantity
- 9504 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0725-2016, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 73221
- Address
- 73 Route 31 N
- Code information
- Lot #: MP4967, Expiry: 04/2016.
- Postal code
- 08534-3601
- Report date
- Mar 2, 2016
- Product type
- Drugs
- Recall number
- D-0725-2016
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 9504 Bottles
- Termination date
- Dec 18, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
- Distribution pattern
- US Nationwide including Puerto Rico
- Recall initiation date
- Jan 14, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 22, 2016