FDA Drug recall D-0653-2016
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only by Macleods Pharma Usa, citing presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0653-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-24 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
Product
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.
Reason
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
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 #: BPA512A; Expiry: 06/2017. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2016%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.