Question 1

Is Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01 recalled?

Accepted Answer

Lupin Pharmaceuticals Inc. has voluntarily recalled 46,479 bottles of Oseltamivir Phosphate for Oral Suspension (6 mg/mL). This prescription medication, commonly used to treat the flu, was found to have an impurity level that exceeded safety specifications during stability testing. Consumers should contact their healthcare provider or pharmacist regarding this recall and for guidance on their treatment.

Question 2

What should I do?

Accepted Answer

Check your medication bottle to see if you have Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, in the 60 mL usable volume size. Verify the identifying numbers on the label: look for NDC 68180-678-01 and specifically check for Lot # A906423 with an expiration date of November 2021 (exp. date Nov 2021). If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance and to discuss alternative treatment options. Return any unused portion of the recalled medication to your pharmacy to receive a refund. Contact Lupin Pharmaceuticals Inc. at their Baltimore office or through their customer service channels if you have specific questions about the product return process. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Lupin Pharmaceuticals Inc.: Oseltamivir Phosphate for Oral Suspension Recalled for Impurity Concerns

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information