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Recall Observatory FDA recall evidence

Drug product

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

May 13, 2019

Class II

Product summary

Firm
American Health Packaging
Event
Event 82863
Status
Terminated
Classification
Class II
Quantity
6,643 cartons
Official record key
drug-enforcement:D-1434-2019

Official wording

Reason: 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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations