Recall events
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Event 82863
Event summary
Timeline bucket May 13, 2019
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording American Health Packaging
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
4 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 4
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
D-1431-2019
Recall number D-1431-2019
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity 3,015 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
GMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information Lot, expiry: Lot 179049, exp 12/31/2019; Lot 182571, exp 8/31/2020
Distribution pattern Nationwide USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[11299]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
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
D-1432-2019
Recall number D-1432-2019
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity 16,698 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
GMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information Lot, expiry: Lot 172669, exp 05/31/2019; Lots 175872, 177086, exp 09/30/2019; Lot 179047, exp 12/31/2019; Lot 182584, exp 07/31/2020
Distribution pattern Nationwide USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[11379]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
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
D-1433-2019
Recall number D-1433-2019
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity 8,777 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
GMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information Lot, expiry: Lots 175820, 176569, exp 09/30/2019; Lots 177866, 179627A, 179627B, exp 12/31/2019; Lot 181627, exp 06/30/2020
Distribution pattern Nationwide USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[11440]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
D-1434-2019
Recall number D-1434-2019
Initiated May 13, 2019
Classification Class II
Status Terminated
Quantity 6,643 cartons
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
GMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Code information Lot, expiry: Lot 176179, exp 05/31/2019; Lot 176616, exp 07/31/2019; Lot 178562, exp 09/30/2019; Lot 179947, exp 12/31/2019; Lot 182048, exp 04/30/2020; Lot 183136, exp 06/30/2020; Lot 184217, exp 08/31/2020
Distribution pattern Nationwide USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[11292]
FDA event record
· Exact recall-number query on openFDA
