Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Reported: December 6, 2017 Initiated: November 20, 2017 #D-0101-2018
Product Description
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Reason for Recall
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 19812 bottles
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 19812 bottles.
Why was this product recalled? ▼
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 6, 2017. Severity: Moderate. Recall number: D-0101-2018.
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