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)
This recall has been terminated (originally issued January 20, 2021).
- Company
- Genus Lifesciences Inc.
- Recall Initiated
- December 23, 2020
- Posted
- January 20, 2021
- Recall Number
- D-0231-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,171,550 cups
- Firm Location
- Allentown, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Distribution
Distributed Nationwide in the USA
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.