D-0231-2021 Class III Terminated
FDA drug recall D-0231-2021 was initiated by Genus Lifesciences Inc. on Dec 23, 2020 and is designated Class III. Reason for recall: Presence of Foreign Substance: Particulate matter was found in multiple lots of product. The recall status is terminated (terminated Nov 5, 2021). Affected quantity: 1,171,550 cups.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 20, 2021
- Initiation Date
- Dec 23, 2020
- Termination Date
- Nov 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,171,550 cups
Product description
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)
Reason for recall
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Distribution pattern
Distributed Nationwide in the USA
Code information
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
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0231-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026