Genus Lifesciences Inc.: Drug Recall

Recall #D-0231-2021 · 12/23/2020

Class III: Low Risk

Recall Details

Recall Number
D-0231-2021
Classification
Class III
Product Type
Drug
Recalling Firm
Genus Lifesciences Inc.
Status
Terminated
Date Initiated
12/23/2020
Location
Allentown, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,171,550 cups

Reason for Recall

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

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)

Distribution Pattern

Distributed Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.