FDA Drug recall D-1433-2019
Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, C…
- FDA Drug
- Class II
- terminated
- Published 2019-07-03
On 2019-07-03 the FDA classified a Class II recall of Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, C… by American Health Packaging, citing GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1433-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-13 |
| Published | 2019-07-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Health Packaging |
| Distribution | US |
Product
Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
Reason
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Identifiers
| code_info | Lot, expiry: Lots 175820, 176569, exp 09/30/2019; Lots 177866, 179627A, 179627B, exp 12/31/2019; Lot 181627, exp 06/30/2020 |
|---|
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-1433-2019%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.