Recall: D-0231-2021

Class III - Minor Violations

Class IIIClassification

2020-12-23Initiated

TerminatedStatus

Genus Lifesciences Inc.Firm

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)

Reason

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

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.