FDA recall D-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)

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-12-23

Report date

2021-01-20

Termination date

2021-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2021