FDA Drug recall D-0101-2018
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…
- FDA Drug
- Class II
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class II recall of 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… by Zydus Pharmaceuticals Usa, citing presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0101-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-20 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Identifiers
| ndc | 68382-097-16 |
|---|---|
| ndc | 68382-097-01 |
| ndc | 68382-097-05 |
| ndc | 68382-097-10 |
| ndc | 68382-097-06 |
| ndc | 68382-098-06 |
| ndc | 68382-098-16 |
| ndc | 68382-098-01 |
| ndc | 68382-098-05 |
| ndc | 68382-098-10 |
| ndc | 68382-099-06 |
| ndc | 68382-099-16 |
| ndc | 68382-099-01 |
| ndc | 68382-099-05 |
| ndc | 68382-099-10 |
| ndc | 68382-001-06 |
| ndc | 68382-001-16 |
| ndc | 68382-001-01 |
| ndc | 68382-001-05 |
| ndc | 68382-001-10 |
| code_info | a) Z701308, b) Z701309, c) Z701310 exp April 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0101-2018%22
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