Risperidone Orally Disintegrating Tablets recall: Impurity Out of Spec
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.
Why was Risperidone Orally Disintegrating Tablets recalled?
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: MP4967, Expiry: 04/2016.
- Product
- 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.
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Quantity
- 9504 Bottles
- Distribution
- US Nationwide including Puerto Rico
- Recall date
- March 2, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)