FDAClass IIIFebruary 10, 2021

Oseltamivir Phosphate for Oral Suspension recall: Impurity Out of Spec

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc.…

Why was Oseltamivir Phosphate for Oral Suspension recalled?

Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

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 # A906423, exp. date Nov 2021.

Product
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc.…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
46,479 bottles
Distribution
Nationwide
Recall date
February 10, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls