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Recall Observatory FDA recall evidence

Drug product

HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.

D-0232-2016

October 07, 2015

Class II

Product summary

Firm
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Event
Event 72397
Status
Terminated
Classification
Class II
Quantity
912 HDPE bottles
Official record key
drug-enforcement:D-0232-2016

Official wording

Reason: Presence of Particulate Matter.

Code information: T084M14A, T085M14A, T086M14A; Exp 12/16

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter