Pramipexole Dihydrochloride Tablets — Class II drug recall D-1432-2019
Terminated recall by American Health Packaging, reported 2019-07-03, distributed nationwide. GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
| Recall number | D-1432-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2019-05-13 |
| Classified | 2019-06-27 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2020-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 16,698 cartons |
| Reason classes | cgmp |
| NDC | 68084-0440-01, 68084-0440-11 |
| Lot numbers | 172669, 175872, 177086, 179047, 182584 |
| Expiration dates | 2019-05-31, 2019-09-30, 2019-12-31, 2020-07-31 |
Product
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
Reason for recall
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1432-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.