FDA Drug recall D-1851-2019
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc
- FDA Drug
- Class III
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class III recall of Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc by Macleods Pharma Usa, citing subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1851-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
Product
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
Reason
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Identifiers
| ndc | 33342-031-10 |
|---|---|
| ndc | 33342-031-15 |
| ndc | 33342-031-06 |
| ndc | 33342-031-12 |
| ndc | 33342-032-10 |
| ndc | 33342-032-15 |
| ndc | 33342-032-06 |
| ndc | 33342-032-12 |
| ndc | 33342-033-10 |
| ndc | 33342-033-15 |
| ndc | 33342-033-06 |
| ndc | 33342-033-12 |
| ndc | 33342-034-10 |
| ndc | 33342-034-15 |
| ndc | 33342-034-06 |
| ndc | 33342-034-12 |
| ndc | 33342-035-10 |
| ndc | 33342-035-15 |
| ndc | 33342-035-06 |
| ndc | 33342-035-12 |
| code_info | Lot #BPA801A, EXP 12/2020 |
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-1851-2019%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.