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Recall Observatory FDA recall evidence

Drug product

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

D-0168-2021

December 07, 2020

Class I

Product summary

Firm
AVKARE Inc.
Event
Event 86940
Status
Terminated
Classification
Class I
Quantity
14368 bottles
Official record key
drug-enforcement:D-0168-2021

Official wording

Reason: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Code information: Lot: 36783 Exp. 06/2022

Distribution pattern: Nationwide within the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.