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Recall Observatory FDA recall evidence

Drug product

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

D-0134-2020

September 24, 2019

Class III

Product summary

Firm
Amneal Pharmaceuticals, Inc.
Event
Event 83915
Status
Terminated
Classification
Class III
Quantity
9,720 100 count bottles
Official record key
drug-enforcement:D-0134-2020

Official wording

Reason: Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Code information: Lot # BB02619A, exp. date 04/2021

Distribution pattern: Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablet