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FDAFDA · Food and drugs·Recall number D-0231-2021

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

Published January 20, 2021 · Recall initiated: December 23, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
OXYCODONE HYDROCHLORIDE
Manufacturer
Genus Lifesciences Inc.
Distributor
Distributed Nationwide in the USA
UPC
0364950353037
Lot
Lot # 35400119A, 35400219A, 35400319A, 35400419A , 35400519A , 35400619A, EXP 12/31/20; 35400719A, 35400819A, EXP 1/31/21; 35400919A, 35401019A, 35401119A, EXP 2/28/21; 35401219A, 35401319A, EXP 4/30/21; 35401419A, 35401519A, 35401619A, EXP 5/31/21; 35401719A, 35401819A, EXP 7/31/21; 35401919A, 35402019A, EXP 8/31/21; 35402119A, 35402219A, 35402319A, 35402419A, EXP 9/30/21; 35402519A, EXP 10/31/21; 35402619A, 35402719A, EXP 11/30/21; 35400120A, 35400220A, 35400320A, 35400420B, EXP 12/31/21; 35400520A, EXP 1/31/22, 35400620A, EXP 1/31/22.
Risk classification
Class III
Area (FDA)
drug
Country
United States

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