Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distribu...
FDA Recall #D-0327-2024 — Class II — February 13, 2024
Product Description
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.
Recalling Firm
Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
46,037 Bottles
Distribution
Nationwide in the USA
Code Information
Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated