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Recall Observatory FDA recall evidence

Drug product

Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99

D-0653-2020

November 19, 2019

Class II

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 84308
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0653-2020

Official wording

Reason: Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..

Code information: Lot #: 19819029A3, Exp. 08/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets