August 2024 FDA Recall Cefixime by Lupin Pharmaceuticals Inc. (D-0648-2024 - Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.)

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on August 21, 2024 for the product Cefixime. The FDA reported the reason for recall as subpotent drug- an out of specification ( oos ) result observed in assay test during 18-month long term stability study.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0648-2024

Reason for Recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Initiated
08-21-2024
Reported
09-04-2024
Quantity
4554 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95193
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-29-2025
Product Description About Product Description
Full technical description of the product.
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Batch or Lot Expiration Information

Lot# : F201517, Exp 11/30/2024

Affected Packages Involved in this Recall

68180-405-01 Cefixime
68180-407-03 Cefixime
68180-407-04 Cefixime
68180-416-08 Cefixime
68180-416-11 Cefixime
68180-423-11 Cefixime
68180-423-08 Cefixime