FDA recall D-0327-2024

Amneal Pharmaceuticals of New York, LLC · Class II · drug

Product

Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6

Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification test results.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2024-02-13
Report date: 2024-02-28
Termination date: 2025-02-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0327-2024