Reported Jan 20, 2021 · Terminated

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05…

Genus Lifesciences Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Genus Lifesciences Inc. · 514 N 12th St · Allentown, PA · 18102-2756

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc
NDC 64950-354-05 Case NDC64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

Lot codes and dates: 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
Amount recalled: 1,171,550 cups

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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