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.
Reported: March 2, 2016 Initiated: January 14, 2016 #D-0725-2016
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 9504 Bottles
- Distribution
- US Nationwide including Puerto Rico
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 9504 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 2, 2016. Severity: Low. Recall number: D-0725-2016.
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