PlainRecalls
FDA Drug Low Class III Terminated

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)

Reported: January 20, 2021 Initiated: December 23, 2020 #D-0231-2021

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)

Reason for Recall

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

Details

Recalling Firm
Genus Lifesciences Inc.
Units Affected
1,171,550 cups
Distribution
Distributed Nationwide in the USA
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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). Recalled by Genus Lifesciences Inc.. Units affected: 1,171,550 cups.
Why was this product recalled?
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 20, 2021. Severity: Low. Recall number: D-0231-2021.