FDAClass IIFebruary 28, 2024

Oseltamivir Phosphate for Oral Suspension 6mg/ml recall: Impurity Out of Spec

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

Why was Oseltamivir Phosphate for Oral Suspension 6mg/ml recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024

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
Recalling firm
Amneal Pharmaceuticals of New York, LLC
Quantity
46,037 Bottles
Distribution
Nationwide in the USA
Recall date
February 28, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls