Drug recall D-0101-2018
Product
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
Lots and codes
a) Z701308, b) Z701309, c) Z701310 exp April 2019
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- 19812 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 20, 2017
- Terminated
- September 1, 2020
Related products
- Paroxetine – drug information
- NDC 68382-097 Paroxetine · Paroxetine Hydrochloride Hemihydrate 10 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-001 Paroxetine · Paroxetine Hydrochloride Hemihydrate 40 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-098 Paroxetine · Paroxetine Hydrochloride Hemihydrate 20 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-099 Paroxetine · Paroxetine Hydrochloride Hemihydrate 30 mg/1 · Zydus Pharmaceuticals USA Inc.