Genus Lifesciences Inc.: 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

Is my product affected?

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)

• Brand OXYCODONE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Genus Lifesciences Inc. is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups due to the presence of particulate matter (foreign substance) found in multiple lots of the product. The recall affects 1,171,550 unit dose cups that were distributed nationwide in the USA. The affected lots have expiration dates ranging from December 31, 2020 through January 31, 2022, and are identified by lot numbers 35400119A through 35400620A.

The source document does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Presence of Foreign Substance: Particulate matter was found in multiple lots of product. Distribution: Distributed Nationwide in the USA Quantity: 1,171,550 cups Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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