FDA-Drug2017-12-06Class II

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

Zydus Pharmaceuticals USA Inc
Hazard

Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets

Sold states
Nationwide
Affected count
19812 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0101-2018

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