TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE ...
FDA Recall #D-0168-2021 — Class I — December 7, 2020
Product Description
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Reason for Recall
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Recalling Firm
AVKARE Inc. — Pulaski, TN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
14368 bottles
Distribution
Nationwide within the U.S.
Code Information
Lot: 36783 Exp. 06/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated