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Recall Observatory FDA recall evidence

Drug product

Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01

D-0091-2018

October 24, 2017

Class II

Product summary

Firm
Amerisource Health Services
Event
Event 78490
Status
Terminated
Classification
Class II
Quantity
74 cartons (cartons of 100 individual unit doses)
Official record key
drug-enforcement:D-0091-2018

Official wording

Reason: Presence of Foreign Tablets/Capsules.

Code information: Lot 172291

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets