FDAClass IIJune 2, 2021

Oseltamivir Phosphate for Oral Suspension 6 mg/mL* recall: CGMP Deviations

Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA

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

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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?

484241

Product
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA
Recalling firm
Cardinal Health Inc.
Quantity
15885 bottles
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls