January 2021 FDA Recall Oseltamivir Phosphate by Lupin Pharmaceuticals Inc.
D-0247-2021 - Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on January 21, 2021 for the product Oseltamivir Phosphate. The FDA reported the reason for recall as failed impurities/degradation specifications; out-of-specification test results observed for impurity c at 9 month long-term stability time point.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0247-2021

Reason for Recall
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Initiated
01-21-2021
Reported
02-10-2021
Quantity
46,479 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87195
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-16-2021
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# A906423, exp. date Nov 2021.

Affected Packages Involved in this Recall

68180-678-01 Oseltamivir Phosphate