FDA Drug recall D-1444-2019
Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed b…
- FDA Drug
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed b… 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-1444-2019 |
| 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 Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Identifiers
| code_info | Lots: M706802, M706804, M706907, M706909, M707028, EXP May-19; M714180, M714181, EXP Oct-19; M717063, M717064, M801705,…Lots: M706802, M706804, M706907, M706909, M707028, EXP May-19; M714180, M714181, EXP Oct-19; M717063, M717064, M801705, M801706, M801707, M801708, M714923, M714924, M714925 EXP Dec-19; M808307, M808308, M808309, M808310, EXP May-20; M812479, M812481, M812482, M812483, EXP Jul-20; M815787 M815789, M815790, M815791, M815788, EXP Sep-20; M820266, M820267, M820268, M820269, M820265 EXP Nov-20; M903040, M903041, M903042 EXP Jan-21. |
|---|
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-1444-2019%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.