FDA Drug recall D-1452-2019
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd
- FDA Drug
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd by Zydus Pharmaceuticals Usa, citing CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1452-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-06 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Identifiers
| code_info | Lots: M713435 M713436 EXP Sep-19; M714191 EXP Oct-19; M808185 M808184 M808186 EXP May-20; M817634 M817635 EXP Nov-20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1452-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.