FDA Drug recall D-1442-2019
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distrib…
- FDA Drug
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distrib… 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-1442-2019 |
| 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 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Identifiers
| code_info | Lot: M714919, EXP Dec-19, M815081, EXP Aug-20, M900475, EXP Dec-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-1442-2019%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.