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Recall Observatory FDA recall evidence

Drug product

HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01

D-0565-2016

October 29, 2015

Class II

Product summary

Firm
Amerisource Health Services
Event
Event 72865
Status
Terminated
Classification
Class II
Quantity
2,784 cartons (278,400 capsules)
Official record key
drug-enforcement:D-0565-2016

Official wording

Reason: Presence of Particulate Matter

Code information: Lot # 151379 and Lot #151380; Exp 12/16

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter