FDA-Drug2021-01-20Class III

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)

Genus Lifesciences Inc.
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
1,171,550 cups
Manufactured in
514 N 12th St, N/A, Allentown, PA, United States
Products
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)

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief