Recalls / Class III
Class IIID-0231-2021
Product
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 name
- Oxycodone Hydrochloride
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDCs
- 64950-354, 64950-353
- FDA application
- NDA200535
- Affected 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.
Why it was recalled
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Recalling firm
- Firm
- Genus Lifesciences Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 514 N 12th St, N/A, Allentown, Pennsylvania 18102-2756
Distribution
- Quantity
- 1,171,550 cups
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-12-23
- FDA classified
- 2021-01-15
- Posted by FDA
- 2021-01-20
- Terminated
- 2021-11-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0231-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.